Latest news with #adalimumab
National Post
7 days ago
- Business
- National Post
US Food and Drug Administration (FDA) Grants Interchangeability Designation to Samsung Bioepis and Organon HADLIMA™ (adalimumab-bwwd) Injection
Article content HADLIMA™ (adalimumab-bwwd) injection, 40 mg/0.4 mL & 40 mg/0.8 mL is now interchangeable with all high- and low-concentration presentations (autoinjector, prefilled syringe, and single-dose vial) of Humira (adalimumab) 1,2 The interchangeability designation for HADLIMA is based on a Pharmacokinetics, Efficacy, Safety, and Immunogenicity study of SB5 versus Humira in patients with moderate to severe chronic plaque psoriasis 3 An interchangeable biosimilar product may be substituted for the reference product without consulting the prescriber, subject to state pharmacy laws 4 Article content Article content INCHEON, Korea & JERSEY CITY, N.J. — Samsung Bioepis Co., Ltd. and Organon & Co. (NYSE: OGN) today announced that the US Food and Drug Administration (FDA) has designated the HADLIMA™ (adalimumab-bwwd) high- and low-concentration (40 mg/0.4 mL, 40 mg/0.8 mL) autoinjectors and high-concentration prefilled syringe as interchangeable biosimilars to Humira ® (adalimumab). 2 These interchangeability designations follow the interchangeability designation received for the HADLIMA low-concentration (40 mg/0.8 mL) prefilled syringe and single-dose vial in June 2024. 1 With today's additional interchangeability designations, HADLIMA is now interchangeable with all presentations of the reference product. 1,2 An interchangeability designation enables a pharmacist to substitute the reference product with a biosimilar without the need to consult the prescriber, depending on state pharmacy laws. 4 Article content 'An increased uptake of biosimilars may lead to improved patient access to biologic therapies and potential savings for the US health care system. 5 As a company dedicated to making medicines more accessible, HADLIMA, now designated as fully interchangeable with the reference product, has a greater potential to bring savings for patients. 1,2,5 As our data shows, on average, patients paid more than four times as much out of pocket per month for Humira compared to HADLIMA,' *6 said Jon Martin, US Commercial Lead, Biosimilars and Established Brands at Organon. 'With this approval, pharmacies can substitute HADLIMA for the reference product Humira without consulting prescribers (subject to state law), which may facilitate increased access for patients to receive the medications they need.' 4,5 Article content 'This designation is meaningful as it signifies our continued commitment to making biosimilars more accessible. Both biosimilars and interchangeable biosimilars are highly similar and have no clinically meaningful differences in safety, purity, and potency compared to the reference product,' 7 said Byoung In Jung, Vice President and Regulatory Affairs Team Leader at Samsung Bioepis. 'With this designation, we continue to benefit patients, health care providers, and health care systems around the world.' Article content HADLIMA is a tumor necrosis factor (TNF) blocker indicated for appropriate patients with rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa, and uveitis. See full indications below. Patients treated with adalimumab products, including HADLIMA, are at increased risk for developing serious infections that may lead to hospitalization or death. Discontinue HADLIMA if a patient develops a serious infection or sepsis. Monitor patients closely for the development of signs and symptoms of infection during and after treatment with HADLIMA, including the possible development of tuberculosis (TB) in patients who tested negative for latent TB infection prior to initiating therapy. Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers including adalimumab products. See additional safety information below. Article content The interchangeability designation was based on clinical data from a randomized, double-blind, 1:1 ratio, parallel-group, multiple-dose clinical trial, which assessed pharmacokinetics (PK), efficacy, safety, and immunogenicity in two treatment groups: patients with moderate to severe plaque psoriasis who switched between formulations of EU-sourced Humira and high-concentration SB5 (adalimumab biosimilar) versus patients receiving Humira continuously. The study demonstrated comparability in terms of primary PK endpoints, as well as efficacy, safety, and immunogenicity profiles between the switching group and continuous Humira treatment group. 3 In addition, data from additional studies provide further evidence to support the interchangeability designation for HADLIMA low- and high-concentration autoinjectors. 8 Article content HADLIMA was first approved by the FDA in 2019 as a low-concentration (40 mg/0.8 mL) formulation of prefilled syringe and autoinjector. The high-concentration (40 mg/0.4 mL) formulation of prefilled syringe and autoinjector of HADLIMA was approved in 2022. 9 Both low- and high-concentration formulations of HADLIMA have been commercially available in the US market since 2023. 10 Article content Rheumatoid Arthritis: HADLIMA is indicated, alone or in combination with methotrexate or other non-biologic disease-modifying antirheumatic drugs (DMARDs), for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. Juvenile Idiopathic Arthritis: HADLIMA is indicated, alone or in combination with methotrexate, for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. Psoriatic Arthritis: HADLIMA is indicated, alone or in combination with non-biologic DMARDs, for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. Ankylosing Spondylitis: HADLIMA is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis. Crohn's Disease: HADLIMA is indicated for the treatment of moderately to severely active Crohn's disease in adults and pediatric patients 6 years of age and older. Ulcerative Colitis: HADLIMA is indicated for the treatment of moderately to severely active ulcerative colitis in adult patients. Limitations of Use: The effectiveness of HADLIMA has not been established in patients who have lost response to or were intolerant to tumor necrosis factor (TNF) blockers. Plaque Psoriasis: HADLIMA is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. HADLIMA should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician. Hidradenitis Suppurativa: HADLIMA is indicated for the treatment of moderate to severe hidradenitis suppurativa in adult patients. Uveitis: HADLIMA is indicated for the treatment of non-infectious intermediate, posterior, and panuveitis in adult patients. Article content Active tuberculosis (TB), including reactivation of latent TB. Patients with TB have frequently presented with disseminated or extrapulmonary disease. Test patients for latent TB before HADLIMA use and during therapy. Initiate treatment for latent TB prior to HADLIMA use. Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Consider empiric anti-fungal therapy in patients at risk for invasive fungal infections who develop severe systemic illness. Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella and Listeria. Article content Carefully consider the risks and benefits of treatment with HADLIMA prior to initiating therapy in patients: Article content Monitor patients closely for the development of signs and symptoms of infection during and after treatment with HADLIMA, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy. Article content Do not start HADLIMA during an active infection, including localized infections. Patients older than 65 years, patients with co-morbid conditions, and/or patients taking concomitant immunosuppressants may be at greater risk of infection. If an infection develops, monitor carefully and initiate appropriate therapy. Drug interactions with biologic products: A higher rate of serious infections has been observed in rheumatoid arthritis (RA) patients treated with rituximab who received subsequent treatment with a TNF blocker. An increased risk of serious infections has been seen with the combination of TNF blockers with anakinra or abatacept, with no demonstrated added benefit in patients with RA. Concomitant administration of HADLIMA with other biologic DMARDs (eg, anakinra or abatacept) or other TNF blockers is not recommended based on the possible increased risk for infections and other potential pharmacological interactions. Article content Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including adalimumab products. Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers, including adalimumab products. These cases have had a very aggressive disease course and have been fatal. The majority of reported TNF blocker cases have occurred in patients with Crohn's disease or ulcerative colitis and the majority were in adolescent and young adult males. Almost all of these patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with a TNF blocker at or prior to diagnosis. It is uncertain whether the occurrence of HSTCL is related to use of a TNF blocker or a TNF blocker in combination with these other immunosuppressants. Article content Consider the risks and benefits of HADLIMA treatment prior to initiating or continuing therapy in a patient with known malignancy. In clinical trials, more cases of malignancies were observed among adalimumab-treated patients compared to control patients. Non-melanoma skin cancer (NMSC) was reported during clinical trials for adalimumab-treated patients. Examine all patients, particularly those with a history of prolonged immunosuppressant or psoralen and ultraviolet A (PUVA) therapy, for the presence of NMSC prior to and during treatment with HADLIMA. In adalimumab clinical trials, there was an approximate 3-fold higher rate of lymphoma than expected in the general U.S. population. Patients with chronic inflammatory diseases, particularly those with highly active disease and/or chronic exposure to immunosuppressant therapies, may be at higher risk of lymphoma than the general population, even in the absence of TNF blockers. Postmarketing cases of acute and chronic leukemia were reported with TNF blocker use. Approximately half of the postmarketing cases of malignancies in children, adolescents, and young adults receiving TNF blockers were lymphomas; other cases included rare malignancies associated with immunosuppression and malignancies not usually observed in children and adolescents. Article content Anaphylaxis and angioneurotic edema have been reported following adalimumab administration. If a serious allergic reaction occurs, stop HADLIMA and institute appropriate therapy. Article content Use of TNF blockers, including HADLIMA, may increase the risk of reactivation of hepatitis B virus (HBV) in patients who are chronic carriers. Some cases have been fatal. Article content Evaluate patients at risk for HBV infection for prior evidence of HBV infection before initiating TNF blocker therapy. Article content Exercise caution in patients who are carriers of HBV and monitor them during and after HADLIMA treatment. Article content Discontinue HADLIMA and begin antiviral therapy in patients who develop HBV reactivation. Exercise caution when resuming HADLIMA after HBV treatment. Article content TNF blockers, including adalimumab products, have been associated with rare cases of new onset or exacerbation of central nervous system and peripheral demyelinating diseases, including multiple sclerosis, optic neuritis, and Guillain-Barré syndrome. Article content Exercise caution when considering HADLIMA for patients with these disorders; discontinuation of HADLIMA should be considered if any of these disorders develop. Article content HEMATOLOGIC REACTIONS Article content Rare reports of pancytopenia, including aplastic anemia, have been reported with TNF blockers. Medically significant cytopenia has been infrequently reported with adalimumab products. Article content Consider stopping HADLIMA if significant hematologic abnormalities occur. Article content CONGESTIVE HEART FAILURE Article content Worsening and new onset congestive heart failure (CHF) has been reported with TNF blockers. Cases of worsening CHF have been observed with adalimumab products; exercise caution and monitor carefully. Article content Treatment with adalimumab products may result in the formation of autoantibodies and, rarely, in development of a lupus-like syndrome. Discontinue treatment if symptoms of a lupus-like syndrome develop. Article content IMMUNIZATIONS Article content Patients on HADLIMA should not receive live vaccines. Article content Pediatric patients, if possible, should be brought up to date with all immunizations before initiating HADLIMA therapy. Article content Adalimumab is actively transferred across the placenta during the third trimester of pregnancy and may affect immune response in the in utero -exposed infant. The safety of administering live or live-attenuated vaccines in infants exposed to adalimumab products in utero is unknown. Risks and benefits should be considered prior to vaccinating (live or live-attenuated) exposed infants. Article content ADVERSE REACTIONS Article content The most common adverse reactions in adalimumab clinical trials (>10%) were: infections (eg, upper respiratory, sinusitis), injection site reactions, headache, and rash. Article content Before prescribing HADLIMA, please read the Prescribing Information, including the Boxed Warning about serious infections and malignancies. The Medication Guide and Instructions for Use also are available. Article content Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing health care that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world's leading biopharmaceutical company. Samsung Bioepis continues to advance a broad pipeline of biosimilar candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, nephrology, and endocrinology. For more information, please visit: and follow us on social media – X, LinkedIn. Article content Organon is an independent global healthcare company with a mission to help improve the health of women throughout their lives. Organon's diverse portfolio offers over 70 medicines and products in women's health, biosimilars, and a large franchise of established medicines across a range of therapeutic areas. In addition to Organon's current products, the company invests in innovative solutions and research to drive future growth opportunities in women's health and biosimilars. Organon is also pursuing opportunities to collaborate with biopharmaceutical partners and innovators who look to commercialize their products by leveraging Organon's scale and agile presence in fast growing international markets. Article content Organon has geographic scope with significant reach, world-class commercial capabilities, and approximately 10,000 employees with headquarters located in Jersey City, New Jersey. Article content HADLIMA is developed, manufactured and supplied by Samsung Bioepis, and commercialized by Organon. Samsung Bioepis and Organon have development and commercialization collaborations for two immunology products and one oncology product in the United States. Article content © 2025 Organon group of companies. All rights reserved. ORGANON and the ORGANON Logo are trademarks of the Organon group of companies. Article content HUMIRA is a trademark registered in the US by AbbVie Biotechnology Ltd.; Organon is not associated with this trademark owner. Article content Except for historical information, this press release includes 'forward-looking statements' within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, including, but not limited to, statements about the potential benefits of biosimilars, as well as Organon's and Samsung's collaboration and the benefits thereof. Forward-looking statements may be identified by words such as 'may,' 'potential,' 'can,' 'should,' 'continue,' 'will,' 'expects,' 'future,' 'opportunity,' or words of similar meaning. These statements are based upon the current beliefs and expectations of Organon's management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate, or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include, but are not limited to, expanded brand and class competition in the markets in which Organon operates; trade protection measures and import or export licensing requirements, including the direct and indirect impacts of tariffs (including any potential pharmaceutical sector tariffs), trade sanctions or similar restrictions by the United States or other governments; changes in U.S. and foreign federal, state and local governmental funding allocations including the timing and amounts allocated to Organon's customers and business partners; economic factors over which Organon has no control, including changes in inflation, interest rates, recessionary pressures, and foreign currency exchange rates; market volatility, downgrades to the U.S. government's sovereign credit rating or its perceived creditworthiness, changing political or geopolitical conditions, market contraction, boycotts, and sanctions, as well as Organon's ability to successfully manage uncertainties related to the foregoing; difficulties with performance of third parties Organon relies on for its business growth; the failure of any supplier to provide substances, materials, or services as agreed; the increased cost of supply, manufacturing, packaging, and operations; difficulties developing and sustaining relationships with commercial counterparties; restructurings or other disruptions at the FDA, the U.S. Securities and Exchange Commission ('SEC') and other U.S. and comparable government agencies; pricing pressures globally, including rules and practices of managed care groups, judicial decisions and governmental laws and regulations related to Medicare, Medicaid and health care reform, pharmaceutical reimbursement and pricing in general; the impact of higher selling and promotional costs; changes in government laws and regulations in the United States and other jurisdictions, including laws and regulations governing the research, development, approval, clearance, manufacturing, supply, distribution, and/or marketing of Organon's products and related intellectual property, environmental regulations, and the enforcement thereof affecting Organon's business; efficacy, safety or other quality concerns with respect to Organon's marketed products, whether or not scientifically justified, leading to product recalls, withdrawals or declining sales; future actions of third parties, including significant changes in customer relationships or changes in the behavior and spending patterns of purchasers of health care products and services, including delaying medical procedures, rationing prescription medications, reducing the frequency of physician visits and forgoing health care insurance coverage; legal factors that could preclude commercialization of products or negatively affect the profitability of existing products; the failure by Organon or its third party collaborators and/or their suppliers to fulfill our or their regulatory or quality obligations, which could lead to a delay in regulatory approval or commercial marketing of Organon's products; and volatility of commodity prices, fuel, shipping rates that impact the costs and/or ability to supply Organon's products. Organon undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Organon's filings with the SEC, including Organon's most recent Annual Report on Form 10-K and subsequent SEC filings, available at the SEC's Internet site ( Article content *Based on an analysis of actual patient claims processed from July 2023 to August 2024, with the average out-of-pocket costs being $215 vs $48 for HUMIRA and HADLIMA, respectively. Article content 1 Approval letter for HADLIMA (adalimumab-bwwd) supplemental biologics license application 761059/S-018. U.S. Food and Drug Administration. June 2024. Article content 2 Approval letter for HADLIMA (adalimumab-bwwd) supplemental biologics license applications 761059/S-025 and 761059/S-026. U.S. Food and Drug Administration. May 2025. Article content 3 Feldman S, Valiukeviciene S, Pulka G, et al. Interchangeability of SB5 and adalimumab reference product in patients with moderate to severe chronic plaque psoriasis. Poster presented at: American Academy of Dermatology Annual Meeting; March 8-12, 2024; San Diego, CA. Accessed May 2025. Article content 4 US Food and Drug Administration. Biosimilar and interchangeable biologics; more treatment choices. Updated August 17, 2023. Accessed May 14, 2025. Article content 5 Aitken M, Kleinrock M, Pritchett J. Biosimilars in the United States 2023-2027: competition, savings, and sustainability. IQVIA Institute for Human Data Science. January 31, 2023. Accessed March 5, 2025. Article content 6 Data available on request from Organon Professional Services-DAP (Marketing Operations), 30 Hudson St., Jersey City, NJ 07302. Please specify information package REF-146241. Article content 7 Biosimilars: Review and approval. US Food and Drug Administration. December 13, 2022. Accessed May 16, 2025. Article content Article content Article content Article content Article content Contacts Article content Organon Media Contacts: Felicia Bisaro (646) 703-1807 Kate Vossen (732) 675-8448 Article content Investor Contacts: Jennifer Halchak (201) 275-2711 Renee McKnight (551) 204-6129 Article content Article content
Health Line
23-05-2025
- Health
- Health Line
Humira Overview: Uses, Dosage, Side Effects, and More
Humira (adalimumab) is a prescription drug that's used to treat certain types of arthritis and other inflammation-related diseases. It comes as a liquid solution for injection under your skin. Specifically, Humira is used to treat: rheumatoid arthritis, psoriatic arthritis, plaque psoriasis, and ankylosing spondylitis in adults plaque psoriasis in adults juvenile idiopathic arthritis in children Crohn's disease and ulcerative colitis in adults and some children hidradenitis suppurativa (a skin condition) in adults and some children uveitis (an eye condition) in adults and some children To learn more about Humira's uses, see the ' What is Humira used for? ' section. What is Humira? Humira (pronounced hu-MARE-ah) is a biologic medication. A biologic is made from parts of living organisms. The active ingredient in Humira is adalimumab. (An active ingredient is what makes a medication work.) There are also biosimilar versions of Humira, such as Amjevita, Cyltezo, and others. Biosimilar drugs are medications that are similar to a brand-name biologic drug. Biosimilars are considered as safe and effective as brand-name biologic drugs and tend to cost less. Humira belongs to a group of drugs called tumor necrosis factor inhibitors, which help reduce inflammation in the body. What is Humira used for? If you have a certain type of arthritis or a disease related to inflammation, your doctor may prescribe Humira for you. Humira is used in certain situations to treat the following conditions: Rheumatoid arthritis: Humira is used to treat rheumatoid arthritis (RA) in adults. The drug can help slow the worsening of this condition. With RA, you have inflammation in your joints. But you may also have problems with other organs in your body. Juvenile idiopathic arthritis: Humira is used to treat moderate to severe juvenile idiopathic arthritis (JIA) in children ages 2 years and older. JIA is a type of arthritis that occurs in children. Psoriatic arthritis: Humira is used to treat psoriatic arthritis (PsA) in adults. The drug helps to slow the worsening of this condition. With PsA, you have inflammation in your joints, and you may also have plaques on your skin, similar to those seen with plaque psoriasis (see below). Ankylosing spondylitis: Humira is used to treat ankylosing spondylitis (AS) in adults. AS and RA are very similar diseases. But people with AS usually have long-lasting lower back pain. This is unlike people with RA, who usually have long-lasting pain in joints in their hands, wrists, or knees. Crohn's disease: Humira is used to treat moderate to severe Crohn's disease in adults and children ages 6 years and older. Crohn's disease is an inflammatory disease that causes swelling in your intestines. Ulcerative colitis: Humira is used to treat moderate to severe ulcerative colitis (UC) in adults and children ages 5 years and older. With UC, you have swelling in your lower intestine. Plaque psoriasis: Humira is used to treat moderate to severe plaque psoriasis in adults. With plaque psoriasis, you may have plaques on the skin of your scalp or trunk, or the skin around your joints. (Plaques are rough, thick, or scaly patches.) Some people with plaque psoriasis develop psoriatic arthritis. Hidradenitis suppurativa: Humira is used to treat moderate to severe hidradenitis suppurativa (HS) in people ages 12 years and older. HS is a skin condition that causes sores on your underarm (axilla) or groin, around your anus, between your anus and urethra, and under your breasts. Uveitis: Humira is used to treat uveitis in adults and children ages 2 years and older. With uveitis, you have inflammation in your eyes that can cause pain and vision loss. How does Humira work? Adalimumab, the active ingredient in Humira, targets a protein in your body called tumor necrosis factor (TNF). This protein increases inflammation in your body. People with inflammatory diseases, such as rheumatoid arthritis or psoriatic arthritis, may have too much TNF in their bloodstream and joints. Blocking TNF is how Humira works for the conditions listed above. What is Humira's dosage? The Humira dosage your doctor prescribes will depend on several factors. These include: the type and severity of the condition you're using Humira to treat your age other medical conditions you may have For some conditions, you may need to start treatment with a loading dose of Humira. A loading dose is a dose that's larger than your regular dose. It allows the drug to start working quickly in your body. Be sure to take the dosage your doctor prescribes for you. Your doctor will determine the best dosage to fit your needs. How to take Humira You'll inject Humira under your skin. Your doctor will show you how to give Humira injections to yourself. Be sure to let your doctor know if you have any questions or concerns about administering the drug to yourself. You'll inject Humira under the skin of: your abdomen, staying 2 inches away from your belly button the front of your thighs Every time you inject a dose of Humira, you should choose a different injection site. And each new injection should be given at least 1 inch away from your last injection site. You should avoid injecting Humira into skin that's: sore bruised discolored hard scarred, including having stretch marks Questions about taking Humira Here are answers to some common questions about taking Humira. What if I miss a dose of Humira? If you miss a dose of Humira, take the missed dose as soon as you remember. Then continue taking Humira doses at your regularly scheduled times. How many days late you can take a Humira dose depends on when your next dose is scheduled. So if it's close to when your next dose is due, just skip the missed dose. If you're unsure of when to take a missed dose of Humira, talk with your doctor or pharmacist. Will I need to use Humira long term? You'll likely need to take Humira long term. This is because most of the conditions Humira treats are long lasting. Talk with your doctor about how long you'll need to take Humira. Should I take Humira with food? You don't have to. How well your body absorbs Humira doesn't depend on whether you have a full or empty stomach. How long does Humira take to work? Depending on the reason you're taking Humira, it may take several months for the drug to work. For example, in studies, people with rheumatoid arthritis saw improvement in their condition after 6 months of treatment. And this improvement was maintained after 1 year when treatment was continued. You might notice Humira working sooner than this for your condition. Talk with your doctor to find out when you should expect to experience a reduction in your symptoms. Overdose Do not take more Humira than your doctor prescribes, as this can lead to harmful effects. What to do in case of overdose Call your doctor if you think you've taken too much Humira. You can also call 800-222-1222 to reach America's Poison Centers or use its online resource. But if you have severe symptoms, immediately call 911 or your local emergency number. Or go to the nearest emergency room. What are Humira's side effects? Like most drugs, Humira may cause mild to serious side effects. The following lists contain some of the more common side effects Humira may cause, but they don't include all possible side effects. Keep in mind that side effects of a drug can depend on: your age other health conditions you have other medications you take The most common Humira side effects reported in the drug's prescribing information include: upper respiratory infections sinusitis injection site reactions headache rash What does Humira cost? Whether you have health insurance or not, cost may be a factor when you're considering Humira. What you'll pay for Humira may depend on several things, such as your treatment plan and the pharmacy you use. Here are a few things to consider regarding cost: Cost information and savings coupons: You can visit Optum Perks for price estimates of Humira. These estimates are based on the use of Optum Perks coupons. Note: Optum Perks coupons cannot be used with insurance copays or benefits. Generic or biosimilar form: Humira is available as the biosimilar drug Amjevita. Similar to generic drugs, biosimilars often cost less than brand-name drugs. Talk with your doctor if you'd like to know whether Amjevita or another biosimilar version of Humira could be a less expensive option for you. Savings options: If you have questions about how to pay for your prescription, talk with your doctor or pharmacist. The Humira manufacturer's website may also have some savings options. Humira interactions Humira can interact with several other medications. It can also interact with certain vaccines. Before using Humira, talk with your doctor and pharmacist. Tell them about all prescription, over-the-counter, and other drugs you take. Also tell them about any vitamins, herbs, or supplements you use. Sharing this information can help you avoid potential interactions. Similar drugs Other drugs may be available that can treat your condition. If you'd like to explore an alternative to Humira, talk with your doctor. They can tell you about other medications that might work well for you. The following drugs are similar to Humira: etanercept (Enbrel) infliximab (Remicade) ustekinumab (Stelara) secukinumab (Cosentyx) vedolizumab (Entyvio) upadacitinib (Rinvoq) certolizumab (Cimzia) risankizumab-rzaa (Skyrizi) tofacitinib (Xeljanz) For information about how some of these alternatives compare with Humira, see these articles: Factors to consider before using Humira The following is important information to consider and discuss with your doctor or pharmacist before using Humira. Pregnancy and Humira Adalimumab, the active ingredient in Humira, passes through the placenta to the developing fetus during the last trimester of pregnancy. But studies don't show a link between Humira use and development problems in pregnancy. It's thought that having unmanaged rheumatoid arthritis or inflammatory bowel disease (such as Crohn's disease) can negatively affect pregnancy. And keep in mind that Humira is used for those conditions. Also, because of how Humira works, doctors will weigh the benefits and risks of giving certain vaccines to babies exposed to Humira during the last trimester of pregnancy. If you're pregnant or considering pregnancy, talk with your doctor before starting Humira. Humira and breastfeeding Humira does pass into breast milk. But side effects from Humira in children who are breastfed haven't been reported. Also, Humira doesn't seem to decrease milk production in people who are breastfeeding. If you're breastfeeding, your doctor will weigh the benefits and risks of Humira treatment. Be sure to talk with your doctor if you'll be breastfeeding while taking Humira. Humira precautions Boxed warnings Humira has boxed warnings about the risk of serious infections and cancer. A boxed warning is the most serious warning from the FDA about drug effects that may be dangerous. Risk of serious infections. Taking Humira can increase your risk for getting a serious infection. This includes tuberculosis, fungal infections, and other rare infections. It may also include bacterial sepsis (a life threatening illness that can result from an infection). Symptoms of a serious infection will vary, but they may include: breathing quickly fast heart rate being confused or disoriented fever chills rash cough If you develop a serious infection or sepsis while you're taking Humira, your doctor will have you stop taking the drug. Call your doctor right away if you have any symptoms of infection while using this drug. Your doctor will also check you for tuberculosis before you start using Humira. And during treatment with Humira, your doctor will monitor you for any signs or symptoms of tuberculosis. Risk of cancer. Some children and adolescents have developed certain types of cancer when taking Humira, such as lymphoma. (This is a type of cancer that affects the lymphatic system.) Other cancers that can be fatal were also reported. Before prescribing Humira, your doctor will consider the benefits and risks of using this drug if you already have cancer. If you develop cancer while you're taking Humira, your doctor will also weigh the benefits and risks of Humira treatment. Your doctor may recommend that you stop taking Humira. Other precautions Before using Humira, discuss your health history with your doctor. Humira may not be right for you if you have certain medical conditions or other factors affecting your health. Be sure to talk with your doctor if any of the following apply to you: Frequently asked questions about Humira Here are answers to some commonly asked questions about Humira. Does Humira cause weight gain or weight loss? No, Humira doesn't cause weight gain or weight loss. But if you get a serious infection during Humira treatment, you might lose weight. And serious infections are a possible side effect of this drug. Also, new or worsening heart failure can cause a rapid increase in weight. Heart failure is a possible side effect of Humira. If you have unexplained weight gain or weight loss when using Humira, tell your doctor. They can try to determine what might be causing your weight change. If you're concerned about any other weight changes while you're taking Humira, talk with your doctor. They can provide tips to help you manage a body weight that's healthy for you. Will I have hair loss with Humira? Possibly. Hair loss wasn't reported as a side effect in Humira's studies. But there have been reports of hair loss in people taking Humira since the drug was approved. If you notice you're losing hair while you're taking Humira, talk with your doctor. What will happen if I stop taking Humira? Will I have withdrawal symptoms? If you stop taking Humira, the symptoms of your condition may come back. But you won't have withdrawal symptoms from the medication itself. (Withdrawal refers to symptoms that can happen if you stop taking a medication that your body is dependent on. Dependence means the body needs the medication to function like usual.) If you need to stop taking Humira, your doctor will closely monitor you for symptoms of your condition. If your symptoms return, your doctor may recommend that you restart treatment with Humira. Or they may suggest another drug to manage your condition. Disclaimer: Healthline has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.
Health Line
23-05-2025
- Health
- Health Line
Does Medicare Cover Humira?
Key takeaways Medicare typically covers Humira through Part D when self-administered or Part B when administered by a doctor. As of 2025, Medicare beneficiaries won't have to pay more than $2,000 out-of-pocket on drugs before Part D coverage kicks in. Various assistance programs, including Medicare Extra Help, Medicaid, PACE, and pharmaceutical assistance programs, are available to lower Humira costs. Humira (adalimumab) is a biologic medication used to treat inflammatory conditions by targeting and blocking TNF-alpha, a protein involved in inflammation. Many of these conditions are chronic, which means they need continued treatment for lifelong management. Medicare typically covers Humira through Part D and Part C. But since Humira is considered a specialty drug, it can be expensive, though many factors play into the cost you'll pay. You may be able to get help paying for the cost of Humira in several ways. Keep reading to learn more about Humira, what parts of Medicare cover it, and how much it may cost you. Can I get Humira on Medicare? Whether or not Medicare covers Humira may depend on how you are taking the drug. Since Humira is an injection, it may be covered through Medicare Part D, Medicare's prescription drug coverage, if you can administer it to yourself at home. If you are not able to administer it yourself at least 50% of the time, Part D may not provide coverage. However, in this case, Medicare Part B may cover Humira if your doctor administers the medication in an outpatient setting. Part D plans are sold by private insurance companies and can be added to your Original Medicare coverage. In order to determine if your specific plan covers Humira, you'll need to check the formulary, which is a list of all the prescription drugs the plan covers. Formularies often include at least two medications for each drug class. If you take Humira, you can find out which plans cover it by comparing different Part D plans. Additionally, the formulary often divides the covered prescription drugs into different tiers. Those listed in higher tiers (tiers 3 to 5) typically cost more than those in lower tiers (tiers 1 and 2). What if I have Medicare Advantage? Medicare Part C is also called Medicare Advantage. Part C plans are sold by private insurance companies, and you can enroll in one as an alternative to Original Medicare. The cost of a Part C plan can vary based on your location. Part D prescription drug coverage is included in most Part C plans. If you want prescription drug coverage with your Part C plan, you'll have to include that coverage when you shop for a plan. You can't enroll in a separate Part D plan if you have Medicare Advantage. As with Part D, it's important to review a Part C plan's formulary to see if the medications you take are listed there. If you have additional questions or concerns, contact your pharmacy or the plan's company directly. Can a Medigap plan help with my costs? Medigap is a form of supplemental insurance sold by private insurance companies. A Medigap plan can help pay for costs that original Medicare (parts A and B) doesn't cover, such as copays. These plans can't be used with Part C (Medicare Advantage). You must choose one or the other. Prior to 2006, some Medigap plans offered coverage to help with prescription drug costs. However, Medigap plans are no longer permitted to offer this coverage. Though these plans have been discontinued, you can usually keep your plan if you're already enrolled in one. How much does Humira cost? Since Humira is a specialty drug, it can be expensive. You may find that Humira is listed in the higher tiers of a plan's formulary. A 2019 study looked at the total cost of Humira by combining the amount that insurance companies paid plus the out-of-pocket costs paid by their beneficiaries. The study found that the median cost of Humira per month was $4,338 in 2017. The costs of Humira under Medicare can depend on where you are in your prescription drug coverage. Let's take a closer look at the costs at each threshold of coverage: Deductible: Each Part D plan has a yearly deductible. For 2025, this cost cannot exceed $590 for any plan. You must pay the deductible out of pocket before your plan will begin to cover your Humira prescription. Coverage: Once you meet your deductible, you pay a copayment or coinsurance when you fill your Humira prescription. The exact amount depends on your specific plan. Spending cap: As of 2025, you won't have to pay more than $2,000 out-of-pocket on drugs before Part D coverage will kick in. A study from early 2020 used data from formularies and pricing files to estimate the yearly out-of-pocket costs for Humira under a Part D plan. These projections indicated that, depending on the dose, Humira could cost an individual between $5,168 and $5,196 in 2019. However, the costs in 2024 are likely a bit higher. How can I get more help to cover my prescription drug costs? If you're concerned about the costs of Humira, you can get help in several ways: Medicare Extra Help Medicare Extra Help is a program that assists people who have limited income or resources with paying for prescription drugs. With Extra Help, you pay no more than $12.15 for brand-name drugs like Humira. If you already have Medicaid, Social Security insurance, or a Medicare savings plan, you'll automatically qualify for Extra Help. Otherwise, you can apply for Extra Help through the Social Security Administration website, as long as you meet certain income limits. Medicaid Medicaid is a federal and state program that helps pay for healthcare for those with lower incomes. While eligibility and benefits can vary by state, Medicaid programs in some states may help with the cost of prescription drugs. You can use the Medicaid website to find information on your state's Medicaid office. PACE Programs of All-Inclusive Care for the Elderly (PACE) is available through Medicare and Medicaid and can help you find care while living at home in your community. One of the benefits that may be covered by PACE is prescription drugs. You can use Medicare's search tool to see if there's a PACE program in your area. For additional information, you can also contact your state's Medicaid office. Pharmaceutical assistance programs Pharmaceutical assistance programs are available through drug manufacturers and other foundations to help you pay for specific medications. To check on pharmaceutical assistance programs for Humira, you can use this Medicare search tool. Additionally, some states may have their own pharmaceutical assistance programs. You can search here to see if your state has one. Pharmacy discount companies Some pharmacy discount companies may offer coupons for Humira. Other companies you can try include GoodRx and SingleCare. Frequently asked questions Does Medicare pay for other biologic injections? Part B may pay for biological injections administered by a healthcare worker at a hospital or clinic. Like with Humira, if you self-administer the drug, Part D may cover it depending on your specific plan and its formulary. What is the cost per month for Humira? A 40-milligram (mg) syringe of Humira now costs about $2,984, or about $77,586 annually, according to the Committee on Oversight and Reform in the U.S. House. The takeaway Medicare typically covers Humira. This coverage is often provided by Medicare Part D or Part C plans. Each insurance company chooses the prescription drugs it covers and lists them in a formulary. Because of this, it's important to check a specific plan's formulary to make sure that Humira is included. While the cost of Humira can potentially be high, numerous programs like Medicare Extra Help and pharmaceutical assistance programs can help lower your costs. The information on this website may assist you in making personal decisions about insurance, but it is not intended to provide advice regarding the purchase or use of any insurance or insurance products. Healthline Media does not transact the business of insurance in any manner and is not licensed as an insurance company or producer in any U.S. jurisdiction. Healthline Media does not recommend or endorse any third parties that may transact the business of insurance.
Yahoo
22-05-2025
- Health
- Yahoo
Celltrion's YUFLYMA® (adalimumab-aaty) receives FDA interchangeability designation for all its approved dosage forms and strengths
YUFLYMA® (adalimumab-aaty) is a high-concentration (100mg/mL) and citrate-free formulation of Humira® (adalimumab) biosimilar[1] Celltrion previously received interchangeability (IC) designation for YUFLYMA® (adalimumab-aaty) in prefilled syringes (20mg & 80mg); Expanded interchangeability (IC) designation applies to prefilled syringe (40mg) and autoinjectors (40mg and 80mg) INCHEON, South Korea, May 21, 2025 /PRNewswire/ -- Celltrion, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted an expanded interchangeable designation for YUFLYMA® (adalimumab-aaty), now including prefilled syringe (40mg) and autoinjectors (40mg and 80mg) presentations. With this approval, YUFLYMA is now fully interchangeable with the reference product, Humira® (adalimumab), across all marketed dosage forms and strengths. YUFLYMA is a high-concentration, citrate-free biosimilar to Humira, approved for multiple inflammatory indications including rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), ulcerative colitis (UC), plaque psoriasis (Ps), hidradenitis suppurativa (HS), and uveitis (UV) in adult patients; Crohn's disease (CD) in adults and pediatric patients 6 years of age and older; and juvenile idiopathic arthritis (JIA) in patients 2 years of age and older.[1] "This full interchangeability designation comes at a pivotal time as Celltrion continues to lead in the evolving biosimilar landscape," said Thomas Nusbickel, Chief Commercial Officer at Celltrion USA. "In alignment with recent federal initiatives aimed at lowering drug costs, we've taken timely action to enhance patient access and affordability. YUFLYMA – a high-concentration, citrate-free adalimumab biosimilar now fully interchangeable with Humira – reflects our long-standing commitment to delivering high-quality, accessible treatment options. Going forward, Celltrion will continue to put patients first by keeping drug costs affordable and remaining at the forefront of the U.S. biosimilar market, bringing competitive pricing and high-quality, accessible treatment options." The interchangeable designation builds on the Phase III interchangeability study, which demonstrated similar outcomes in terms of pharmacokinetics, efficacy, safety and immunogenicity in patients with moderately to severely active plaque psoriasis who received reference adalimumab (ADA) continuously and those who alternated between reference ADA and YUFLYMA during the dosing interval of Weeks 25-27. The result of the interchangeability study was presented at the European Academy of Dermatology & Venereology (EADV), September 2024, in the Netherlands.[2] The expanded interchangeability designation for YUFLYMA is complemented by a strategic price reduction that reflects Celltrion's ongoing commitment to improving patient access while aligning with federal efforts to lower drug prices. Effective immediately, the wholesale acquisition cost (WAC) list price of YUFLYMA has been reduced to $948 per syringe, and the updated pricing has been uploaded to the national pricing compendia. YUFLYMA was first introduced in the U.S. market in July 2023 and is currently available as a 20mg, 40mg, and 80mg solution for injection in prefilled syringes and as 40mg and 80mg in autoinjectors. Celltrion offers adalimumab-aaty in both branded and unbranded versions, with two pricing options to meet different patient needs and improve patient affordability. Notes to Editors: About YUFLYMA® (CT-P17, biosimilar adalimumab-aaty)[1] YUFLYMA is a high-concentration, low-volume and citrate-free adalimumab biosimilar to receive European Commission approval. YUFLYMA is FDA approved for the treatment of patients with rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa and uveitis. YUFLYMA has been designated by the FDA as an interchangeable biosimilar in a prefilled syringe and autoinjector. YUFLYMA is a recombinant fully human anti–tumor necrosis factor α (anti-TNFα) monoclonal antibody. YUFLYMA is available in prefilled syringe as 20mg/0.2mL, 40mg/0.4mL and 80mg/0.8mL and autoinjector as 40mg/0.4mL and 80mg/0.8mL. Additionally, YUFLYMA features one of the longest shelf lives in its class, maintaining stability at room temperature (77 °F, 25 °C) for up to 31 days. IMPORTANT SAFETY INFORMATION[1]This important safety information also applies to YUFLYMA® (adalimumab-aaty). SERIOUS INFECTIONS Patients treated with adalimumab-aaty are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Discontinue adalimumab-aaty if a patient develops a serious infection or sepsis. Reported infections include: Active tuberculosis (TB), including reactivation of latent TB. Patients with TB have frequently presented with disseminated or extrapulmonary disease. Test patients for latent TB before adalimumab-aaty use and during therapy. Initiate treatment for latent TB prior to adalimumab-aaty use. Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Consider empiric antifungal therapy in patients at risk for invasive fungal infections who develop severe systemic illness. Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella and Listeria. Carefully consider the risks and benefits of treatment with adalimumab-aaty prior to initiating therapy in patients with chronic or recurrent infection. Monitor patients closely for the development of signs and symptoms of infection during and after treatment with adalimumab-aaty, including the possible development of TB in patients who tested negative for latent TB infection prior to initiating therapy. Treatment with adalimumab-aaty should not be initiated in patients with an active infection, including localized infections. Patients over 65 years of age, patients with co-morbid conditions and/or patients taking concomitant immunosuppressants (such as corticosteroids or methotrexate), may be at greater risk of infection. Discontinue adalimumab-aaty if a patient develops a serious infection or sepsis. For a patient who develops a new infection during treatment with adalimumab-aaty, closely monitor them, perform a prompt and complete diagnostic workup appropriate for an immunocompromised patient, and initiate appropriate antimicrobial therapy. Drug interactions with biologic products: In clinical studies in patients with RA, an increased risk of serious infections has been observed with the combination of TNF blockers with anakinra or abatacept, with no added benefit; therefore, use of adalimumab-aaty with abatacept or anakinra is not recommended in patients with RA. A higher rate of serious infections has also been observed in patients with RA treated with rituximab who received subsequent treatment with a TNF blocker. There is insufficient information regarding the concomitant use of adalimumab-aaty and other biologic products for the treatment of RA, PsA, AS, CD, UC, PS, and HS. Concomitant administration of adalimumab-aaty with other biologic disease-modifying antirheumatic drugs (DMARDs) (e.g., anakinra and abatacept) or other TNF blockers is not recommended based upon the possible increased risk for infections and other potential pharmacological interactions. A higher rate of serious infections has been observed in RA patients treated with rituximab who received subsequent treatment with a TNF blocker. MALIGNANCY Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including adalimumab products. Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers, including adalimumab products. These cases have had a very aggressive disease course and have been fatal. The majority of reported TNF blocker cases have occurred in patients with Crohn's disease or ulcerative colitis and the majority were in adolescent and young adult males. Almost all of these patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with a TNF blocker at or prior to diagnosis. It is uncertain whether the occurrence of HSTCL is related to the use of a TNF blocker or a TNF blocker in combination with these other immunosuppressants. Consider the risks and benefits of TNF blocker treatment including adalimumab-aaty prior to initiating therapy in patients with a known malignancy other than a successfully treated non-melanoma skin cancer (NMSC), or when considering continuing a TNF blocker in patients who develop a malignancy. In controlled portions of clinical trials of some adalimumab products, more cases of malignancies have been observed compared to control-treated adult patients. NMSC was reported during clinical trials for patients treated with adalimumab products. During the controlled portions of 39 global adalimumab clinical trials in adult patients with RA, PsA, AS, CD, UC, PS, HS and UV, the rate (95% confidence interval) of NMSC was 0.8 (0.52, 1.09) per 100 patient-years among adalimumab-treated patients and 0.2 (0.10, 0.59) per 100 patient-years among control-treated patients. Examine all patients, particularly those with a medical history of prior prolonged immunosuppressant therapy or psoriasis patients with a history of psoralen + ultraviolet light A (PUVA) treatment, for the presence of NMSC prior to and during treatment with adalimumab-aaty. In clinical trials of some adalimumab products, there was an approximately threefold higher rate of lymphoma than expected in the general U.S. population. Patients with RA and other chronic inflammatory diseases, particularly those with highly active disease and/or chronic exposure to immunosuppressant therapies, may be at a higher risk (up to severalfold) than the general population for the development of lymphoma, even in the absence of TNF blockers. Postmarketing cases of acute and chronic leukemia were reported with the use of a TNF blocker in RA and other indications. Approximately half of the postmarketing cases of malignancies in children, adolescents, and young adults receiving adalimumab were lymphomas; other cases represented a variety of different malignancies and included rare malignancies usually associated with immunosuppression and malignancies that are not usually observed in children and adolescents. HYPERSENSITIVITY Anaphylaxis and angioneurotic edema have been reported following administration of adalimumab products. If an anaphylactic or other serious allergic reaction occurs, immediately discontinue administration of adalimumab-aaty and institute appropriate therapy. HEPATITIS B VIRUS REACTIVATION Use of TNF blockers, including adalimumab-aaty, may increase the risk of reactivation of hepatitis B virus (HBV) in patients who are chronic carriers. In some instances, HBV reactivation occurring in conjunction with TNF blocker therapy has been fatal. Evaluate patients at risk for HBV infection for prior evidence of HBV infection before initiating TNF blocker therapy. Exercise caution in prescribing TNF blockers for patients identified as carriers of HBV and closely monitor such patients for clinical and laboratory signs of active HBV infection throughout therapy and for several months following termination of therapy. In patients who develop HBV reactivation, stop adalimumab-aaty and initiate effective antiviral therapy with appropriate supportive treatment. The safety of resuming TNF blocker therapy after HBV reactivation is controlled is not known. Therefore, exercise caution when considering resumption of adalimumab-aaty therapy in this situation and monitor patients closely. NEUROLOGIC REACTIONS Use of TNF blocking agents, including adalimumab products, has been associated with rare cases of new onset or exacerbation of clinical symptoms and/or radiographic evidence of central nervous system demyelinating disease, including multiple sclerosis (MS) and optic neuritis, and peripheral demyelinating disease, including Guillain-Barré syndrome. Exercise caution in considering the use of adalimumab-aaty in patients with preexisting or recent-onset central or peripheral nervous system demyelinating disorders; discontinuation of adalimumab-aaty should be considered if any of these disorders develop. There is a known association between intermediate uveitis and central demyelinating disorders. HEMATOLOGIC REACTIONS Rare reports of pancytopenia including aplastic anemia have been reported with TNF blocking agents. Adverse reactions of the hematologic system, including medically significant cytopenia, have been infrequently reported with adalimumab products. Consider discontinuation of adalimumab-aaty therapy in patients with confirmed significant hematologic abnormalities. HEART FAILURE Cases of worsening congestive heart failure (CHF) and new-onset CHF have been reported with TNF blockers. Cases of worsening CHF have also been observed with adalimumab products. Exercise caution when using adalimumab-aaty in patients who have heart failure and monitor them carefully. AUTOIMMUNITY Treatment with adalimumab products may result in the formation of autoantibodies and, rarely, in the development of a lupus-like syndrome. If a patient develops symptoms suggestive of a lupus-like syndrome following treatment with adalimumab-aaty, discontinue treatment. IMMUNIZATIONS Patients on adalimumab-aaty may receive concurrent vaccinations, except for live vaccines. It is recommended that pediatric patients, if possible, be brought up to date with all immunizations in agreement with current immunization guidelines prior to initiating adalimumab-aaty therapy. No data are available on the secondary transmission of infection by live vaccines in patients receiving adalimumab products. The safety of administering live or live-attenuated vaccines in infants exposed to adalimumab in utero is unknown. Risks and benefits should be considered prior to vaccinating (live or live-attenuated) exposed infants. ADVERSE REACTIONS The most common adverse reactions in adalimumab clinical trials (>10%) were infections (e.g., upper respiratory, sinusitis), injection site reactions, headache, and rash. INDICATIONS Adalimumab-aaty is a tumor necrosis factor (TNF) blocker indicated for: Rheumatoid Arthritis (RA): reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA Juvenile Idiopathic Arthritis (JIA): reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older Psoriatic Arthritis (PsA): reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA Ankylosing Spondylitis (AS): reducing signs and symptoms in adult patients with active AS Crohn's Disease (CD): treatment of moderately to severely active Crohn's disease in adults and pediatric patients 6 years of age and older Ulcerative Colitis (UC): treatment of moderately to severely active ulcerative colitis in adults Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers Plaque Psoriasis (Ps): treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate Hidradenitis Suppurativa (HS): treatment of adult patients with moderate to severe hidradenitis suppurativa Uveitis (UV): treatment of non-infectious intermediate, posterior, and panuveitis in adult patients For Yuflyma (adalimumab-aaty): Please click for Full U.S. Prescribing Information. For adalimumab-aaty: Please see Full U.S. Prescribing Information. Globally, prescribing information varies; refer to the individual country product label for complete information. About Celltrion, Inc. Celltrion is a leading biopharmaceutical company that specializes in researching, developing, manufacturing, marketing and sales of innovative therapeutics that improve people's lives worldwide. Celltrion is a pioneer in the biosimilar space, having launched the world's first monoclonal antibody biosimilar. Our global pharmaceutical portfolio addresses a range of therapeutic areas including immunology, oncology, hematology, ophthalmology and endocrinology. Beyond biosimilar products, we are committed to advancing our pipeline with novel drugs to push the boundaries of scientific innovation and deliver quality medicines. For more information, please visit our website and stay updated with our latest news and events on our social media: LinkedIn, Instagram, X, and Facebook. About Celltrion USA Celltrion USA is Celltrion's U.S. subsidiary established in 2018. Headquartered in New Jersey, Celltrion USA is committed to expanding access to innovative biologics to improve care for U.S. patients. Celltrion's FDA-approved biosimilar products in immunology, oncology, hematology, and endocrinology include: INFLECTRA® (infliximab-dyyb), TRUXIMA® (rituximab-abbs), HERZUMA® (trastuzumab-pkrb), VEGZELMA® (bevacizumab-adcd), YUFLYMA®(adalimumab-aaty), AVTOZMA® (tocilizumab-anho), STEQEYMA® (ustekinumab-stba), STOBOCLO® (denosumab-bmwo), OSENVELT® (denosumab-bmwo) and OMLYCLO® (omalizumab-igec), as well as the novel biologic ZYMFENTRA® (infliximab-dyyb). Celltrion USA will continue to leverage Celltrion's unique heritage in biotechnology, supply chain excellence and best-in-class sales capabilities to improve access to high-quality biopharmaceuticals for U.S. patients. For more information, please visit and stay updated with our latest news and events on LinkedIn. FORWARD-LOOKING STATEMENT Certain information set forth in this press release contains statements related to our future business and financial performance and future events or developments involving Celltrion, Inc. and its subsidiaries that may constitute forward-looking statements under pertinent securities laws. This press release contains forward looking statements. These statements may be also identified by words such as "prepares", "hopes to", "upcoming", "plans to", "aims to", "to be launched", "is preparing", "once gained", "could", "with the aim of", "may", "once identified", "will", "working towards", "is due", "become available", "has potential to", "anticipate" the negative of these words or such other variations thereon or comparable terminology. In addition, our representatives may make oral forward-looking statements. Such statements are based on the current expectations and certain assumptions of Celltrion, Inc. and its subsidiaries' management, of which many are beyond its control. Forward-looking statements are provided to allow potential investors the opportunity to understand management's beliefs and opinions in respect of the future so that they may use such beliefs and opinions as one factor in evaluating an investment. These statements are not guarantees of future performance and undue reliance should not be placed on them. Such forward-looking statements necessarily involve known and unknown risks and uncertainties associated with the company's business, including the risk factors disclosed in its Annual Report and/or Quarterly Reports, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or results expressed or implied by such statements. Celltrion, Inc. and its subsidiaries undertake no obligation to update forward-looking statements if circumstances or management's estimates or opinions should change except as required by applicable securities laws. Trademarks Humira is a registered trademark of AbbVie. YUFLYMA® is a registered trademark of Celltrion, Inc., used under license. References [1] YUFLYMA US prescribing information (2023) [2] Lebwohl M et al., Pharmacokinetics, Efficacy and Safety after Multiple Switches from Reference Adalimumab to Adalimumab Biosimilar (CT-P17) in comparison with the Maintenance Group (Reference Adalimumab) in Patients with Moderate-toSevere Plaque Psoriasis: Week 27 Results from the Phase III Interchangeability Study. [EADV 2024, Poster number P0931]. Available at: For further information please contact: Andria Arenaaarena@ +1 516-578-0057 View original content to download multimedia: SOURCE Celltrion Sign in to access your portfolio
Forbes
09-05-2025
- Business
- Forbes
Dutch Court Case On Humira Assesses Whether Its Price Was `Excessive'
Packaging for AbbVie's drug, Humira (adalimumab). The Pharmaceutical Accountability Foundation in ... More the Netherlands alleges in court that AbbVie made "excessive profits" during the period from 2014 to 2018, prior to its going off patent in Europe. AbbVie denies the allegations. (AP Photo/David J. Phillip, File) In a unique legal challenge, the Dutch Pharmaceutical Accountability Foundation is taking on the manufacturer of Humira (adalimumab), AbbVie, in a Dutch court today, May 9th, for alleged excessive profiteering. The Foundation is not seeking financial damages. Rather it wants a panel of judges to rule on the principle of what constitutes a reasonable profit. At the heart of the case is the question of whether there ought to be limits to what a company can charge for medicines. The Foundation accuses AbbVie of 'abusing' its dominant position in the market as a monopoly to make excessive profits, hereby also violating certain 'human rights,' such as people's 'right to health.' In this context, the plaintiff calculated such profits by subtracting from the revenues—AbbVie's Humira sales in the Netherlands were €2.1 ($2.36) billion from 2004 to when the product's patent expired in 2018—research and development, production and distribution costs, and what the Foundation opined is a 'fair' profit, leaving €1($1.13) billion as 'excess.' The Pharmaceutical Accountability Foundation is an independent, public good foundation under Dutch law that says it works to 'ensure equitable, affordable access to medicines for all.' Humira has been a blockbuster medication worldwide for two decades. The biologic has multiple indications, including rheumatoid arthritis, Crohn's disease and psoriasis. Humira still has billions of dollars in sales in the United States, where biosimilar traction has been slow, due initially to litigation which prevented biosimilars from entering the market until 2023 and subsequently a sub-optimally operating drug supply chain. Humira's market share remains quite high at 70% despite the competition. In addition, biosimilar discounts aren't as steep as they are outside the U.S., including the Netherlands. The Dutch Healthcare Authority, an agency of the Dutch Ministry of Health, Welfare and Sport released a report last month which noted that annual per patient spending on adalimumab-based products in the Netherlands fell nearly 90% in 2018, from €10,400($11,713) during Humira's patent period to €1,300($1,464) once biosimilar competition was introduced. Biosimilars are very close in molecular structure and function to their referenced, brand name originator biologic medicines. There are also no clinically meaningful differences in effectiveness. Humira is an originator with numerous referenced biosimilars. In an initial court proceeding in 2023, the Foundation accused AbbVie of engaging in "unfair, excessive pricing practices." It invoked the importance of considering opportunity costs when evaluating expenditures on Humira: 'The Dutch government has set a maximum budget for healthcare. That means you have to make choices. You can only spend every euro once. And we see that because drug manufacturers charge too high a price, other drugs or services cannot be delivered.' Moreover, the Foundation suggests that ordinary Dutch citizens are negatively impacted financially, as they 'pay for the [excessive profit], through higher and higher [health insurance] premiums.' The Foundation's long-term goals are to establish legally enforceable regulations that ensure medicines are fairly priced at 'socially acceptable' levels. Additionally, the organization seeks a way to mandate more transparency from pharmaceutical firms with respect to research and development costs, the share of public funding and profit margins. AbbVie has said in response to the legal complaint that it acts in accordance with all Dutch laws and regulations. The company categorically rejects the Foundation's allegations. Furthermore, AbbVie says that the costs of failed development projects, expansion of indications and related studies have not been adequately accounted for in the plaintiff's argument. Nor were appropriate discounts negotiated with healthcare providers included in the calculations, according to AbbVie. Te defendant also takes issue with allegations that Humira's price was 'too high.' In the Netherlands, when a drug launches, manufacturers face multiple entities, including the National Health Care Institute and the Ministry of Health, Welfare, and Sport, with whom they negotiate the medication's pricing and reimbursement. Presumably, at the time Humira launched, AbbVie negotiated an acceptable price with the relevant authorities. Generally, profiteering or price gouging is considered the practice of increasing the prices of goods to a level 'much higher' than is considered 'reasonable or fair.' More often than not, the term is associated with sellers taking advantage of circumstances that decrease supply. This would include, for example, emergencies causing severe supply-side constraints. While Humira did enjoy a period during which it was a monopoly, which lasted until 2018 in Europe, there weren't any supply limitations per se that AbbVie would have been exploiting. This in turn raises questions about whether the Foundation's reasoning regarding 'excessive profits' will be accepted in court. Nevertheless, the overarching problem of rising expenditures on what the government calls 'expensive drugs" has worsened recently. In the eyes of the Foundation this may be exacerbated by "unreasonable prices" which make it harder to maintain a sustainable healthcare system in which there is universal access to an essential package of benefits. If the Foundation's challenge is successful, this could establish a precedent in the Netherlands, and perhaps Europe more broadly, on price and profit limits. A decision by a panel of judges on whether AbbVie acted unlawfully is expected in six to 12 weeks.
