Latest news with #STELARA
Yahoo
08-08-2025
- Business
- Yahoo
Bet on JNJ & Hold on to Apple to Grow Your Retirement Fund Stress-Free
In a well-balanced retirement portfolio, investors should aim for a mix of defensive and growth stocks. This approach offers both stability and the potential for wealth creation over time. By investing in Johnson & Johnson JNJ and holding on to Apple Inc. AAPL, you get the best of both worlds — the reliability and income of a proven healthcare leader and the innovation and growth of a global tech giant. JNJ: Stability & Steady Growth in Any Market Johnson & Johnson is a reliable investment because it is a leading provider of essential healthcare products that people need, regardless of economic conditions. Notably, despite losing exclusivity for its blockbuster drug STELARA, the company's second-quarter 2025 operational sales increased 4.6%, proving its resilience. This shows that Johnson & Johnson is strong and can continue to grow even when facing challenges. Interestingly, JNJ's uniquely diversified business comprises both important medicines — like cancer drugs CARVYKTI and DARZALEX — and life-saving medical devices, such as tools that help patients recover from heart problems. Because it doesn't depend on just one product to succeed, its business is more stable and less risky. Also, JNJ's balance sheet is strong, as reflected in $19 billion in cash and marketable securities, and a debt-to-capitalization of 39.3%. Thus, the company can lean on its balance sheet strength to sail through an unfavorable business environment. Overall, the stability of JNJ's business model lies in its ability to generate substantial free cash flow ($6 billion in the second quarter of 2025), which it believes to strategically allocate toward mergers and acquisitions as well as returning capital to shareholders through dividends and share repurchases. Image Source: Johnson & Johnson AAPL: Innovation Engine Powering Long-Term Growth We all know that Apple is not just selling phones or laptops, but rather that the tech giant is creating a connected world that keeps people coming back. In its fiscal 2025 third quarter, AAPL's newest iPhones helped boost sales by 13%, while Mac sales rose 15%, and its Services business (like iCloud and Apple Music) reached a record high. More people than ever are upgrading their devices, drawn in by exciting new features like faster chips, smarter AI and sleek new designs. Importantly, the number of Apple devices in use worldwide hit a new record, showing that customers aren't switching brands—they're sticking with Apple and buying even more of its products. What's more, Apple has a strong growth opportunity because it's constantly finding new ways to make money and stay ahead of the curve. Big trends like artificial intelligence (through Apple Intelligence), new tech like the Vision Pro headset and expanding into fast-growing regions like India and the Middle East are boosting its future potential. This combination of brand loyalty, innovation and expanding markets makes Apple a compelling growth engine for the long term. What Investors Should Do Now? Given the current market backdrop, it's important to look at how both JNJ and AAPL are valued before making any investment decisions. JNJ, carrying a Zacks Rank #2 (Buy), is currently trading at a trailing 12-month P/E of 17.15x, below the industry average of 22.26x. This suggests the stock is undervalued, offering a potentially attractive entry point for investors. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. Image Source: Zacks Investment Research In contrast, Apple, carrying a Zacks Rank #3 (Hold), trades at a trailing P/E of 30.31x, which is higher than the industry average of 28.38x. This indicates the stock is relatively expensive at current levels. Therefore, while new investors may want to wait for a better entry point, existing shareholders can continue to hold Apple for its long-term potential. Image Source: Zacks Investment Research Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Apple Inc. (AAPL) : Free Stock Analysis Report Johnson & Johnson (JNJ) : Free Stock Analysis Report This article originally published on Zacks Investment Research ( Zacks Investment Research Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
23-07-2025
- Business
- Yahoo
Johnson & Johnson (JNJ)'s Pasritamig Shows Breakthrough Promise in Prostate Cancer
We recently published Johnson & Johnson stands second among the most undervalued stocks. Johnson & Johnson (NYSE:JNJ) is a global healthcare leader with a diverse portfolio across pharmaceuticals, medical devices, and consumer health. Its Innovative Medicine division focuses on treatments for complex diseases, while MedTech develops minimally invasive solutions in cardiovascular, orthopedic, surgical, and vision care. In June 2025, Johnson & Johnson (NYSE:JNJ) reported promising Phase 1 results for pasritamig (JNJ-78278343), a first-in-class bispecific T-cell-engaging antibody for metastatic castration-resistant prostate cancer (mCRPC). The drug targets KLK2, a prostate cancer-specific biomarker, and showed early antitumor activity with low treatment-related side effects, indicating potential for safe outpatient use. Pixabay/Public Domain Other notable advances include a supplemental FDA application for STELARA to treat pediatric Crohn's disease, and early Phase 1b data showing encouraging responses from bleximenib—a menin inhibitor—combined with venetoclax and azacitidine for genetically defined acute myeloid leukemia (AML). In vision care, the company launched the first daily disposable multifocal toric contact lens for astigmatism: ACUVUE OASYS MAX 1-Day MULTIFOCAL. Strategically, Johnson & Johnson (NYSE:JNJ) plans to invest $55 billion over four years to expand U.S.-based manufacturing and R&D, aligning with efforts to boost domestic production and supply chain resilience. While we acknowledge the potential of JNJ as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: 30 Stocks That Should Double in 3 Years and 11 Hidden AI Stocks to Buy Right Now. Disclosure: None. Error while retrieving data Sign in to access your portfolio Error while retrieving data Error while retrieving data Error while retrieving data Error while retrieving data
Business Insider
22-07-2025
- Business
- Business Insider
Johnson & Johnson Stock (JNJ) Bulls Target Breakout Despite Looming Patent Cliff
Johnson & Johnson (JNJ) stock is gaining momentum this week following last week's impressive second-quarter 2025 earnings report. While many large pharmaceutical firms are grappling with 'patent cliffs'—the loss of exclusivity for blockbuster drugs—Johnson & Johnson is defying the trend thanks to its well-balanced portfolio of pharmaceuticals and medical devices. Elevate Your Investing Strategy: Take advantage of TipRanks Premium at 50% off! Unlock powerful investing tools, advanced data, and expert analyst insights to help you invest with confidence. Make smarter investment decisions with TipRanks' Smart Investor Picks, delivered to your inbox every week. What truly stood out wasn't just the strong quarterly performance but also management's upgraded outlook for the full year. The company raised its revenue forecast by $2 billion and bumped up its adjusted EPS guidance by $0.25, signaling confidence in its ability to navigate the looming STELARA patent expiration. With this shift, I believe the stock is poised to break out of its five-year stagnation, reinforcing my Bullish stance. Q2 2025 Performance Hits Top Gear A deeper look at Johnson & Johnson's Q2 earnings reveals solid growth, with global sales reaching $23.7 billion—up 5.8% year-over-year—and net earnings climbing 18.2% to $5.5 billion. According to TipRanks data, the company clearly fits the definition of a 'cash cow,' having generated $6.2 billion in free cash flow during the quarter. While it carries a net debt of $32 billion (with $19 billion in cash and $51 billion in total debt), that burden is offset by its strong cash flow, underscoring the company's fundamentally sound financial position. Johnson & Johnson Looks Beyond STELARA Although STELARA's quarterly sales dropped 42.7% year-over-year to $1.65 billion, Johnson & Johnson more than made up for it with strong performance across other areas of its pharmaceutical portfolio. The standout gains came from its Oncology and Neuroscience segments. In Oncology, therapies like DARZALEX and CARVYKTI drove notable growth, with CARVYKTI—a cutting-edge CAR T-cell treatment—more than doubling its sales year-over-year to $439 million in the high-potential multiple myeloma market. On the Neuroscience front, CAPLYTA generated an impressive $211 million in sales, exceeding expectations. Johnson & Johnson acquired the drug through its $14.6 billion purchase of Intra-Cellular Therapies in April this year. As an FDA-approved treatment for bipolar depression and schizophrenia, CAPLYTA stands out as a differentiated atypical antipsychotic. With potential supplemental approvals on the horizon—for schizophrenia relapse prevention and adjunctive use in major depressive disorder—its total addressable market could expand significantly. MedTech Serves as Supplemental Revenue Stream Johnson & Johnson's medical devices division continues to show steady momentum, with global sales rising 6.1% year-over-year to $8.5 billion, according to TipRanks data. The standout performer was Cardiovascular surgery, which saw 22% growth—largely fueled by strong demand for the company's electrophysiology products and the Impella heart pump. Although the MedTech segment isn't as high-margin as the Innovative Medicines division, it plays a vital role in diversifying the company's revenue streams. Medical devices carry different risk profiles compared to pharmaceuticals, and in that sense, Johnson & Johnson benefits from having its bets spread across distinct sectors. Mitigating the Impact of Trump's Tariffs The company's progress occurs amid a macroeconomic environment that affects every business. However, Johnson & Johnson appears more resilient than others. It slashed its estimate for the impact of tariffs in 2025 from $400 million to around $200 million, primarily due to supply chain optimization. In the long run, Johnson & Johnson has committed to a $55 billion investment over the next three years to increase its U.S. manufacturing capacity and has declared its intention to manufacture all U.S.-prescribed medicines in the U.S. to mitigate future disruptions from trade wars and tariffs. Potential Risks and Headwinds on JNJ's Radar That said, it's essential to acknowledge the risks. Johnson & Johnson continues to face ongoing litigation related to its talc-based products. While it has already paid several billion dollars in settlements, additional liabilities could still arise. On the macroeconomic front, cost pressures are weighing on profitability, as evident in the MedTech segment, where margins declined from 25.7% to 22.2%. Competition remains intense across both business units, with major players like Medtronic (MDT), Abbott (ABT), and Pfizer (PFE) posing constant challenges. Lastly, the company's ability to maintain momentum hinges on the continued success of its newer drugs, which must offset the revenue decline from STELARA's loss of exclusivity. Is JNJ a Good Stock to Buy Now? On Wall Street, JNJ carries a Moderate Buy consensus rating based on eight Buy, ten Hold, and zero Sell ratings in the past three months. JNJ's average stock price target of $176.35 implies an upside potential of ~8% over the next 12 months. Just last week, Goldman Sachs analyst Asad Haider reiterated a Buy rating on Johnson & Johnson, citing strong second-quarter results as a key driver of his optimism. Haider noted that the company's decision to raise its 2025 guidance signals confidence in its outlook, with expected growth in both operational and reported revenues. He pointed to the continued strength of the Innovative Medicines division—particularly with standout products like Tremfya, Carvykti, and Darzalex—as effectively countering headwinds from Stelara's biosimilar competition. According to Haider, this positive momentum in earnings and sales forecasts positions JNJ ahead of both peers and the broader market. JNJ Prepares for Bullish Upside Without STELARA Johnson & Johnson is managing the STELARA patent cliff with notable poise. Strength in its Neuroscience and Oncology portfolios is helping to offset the declines in its legacy Immunology segment. At the same time, its dependable MedTech division continues to provide a stable foundation. Looking ahead, the company's ambitions are bold. It aims for $50 billion in annual oncology sales by 2030, driven by established therapies like CARVYKTI and promising pipeline candidates, such as TAR-200, for bladder cancer. While risks remain, many appear already priced into the stock. With a P/E ratio of 17.4—representing a 34% discount to the healthcare sector median —JNJ looks attractively valued. A successful transition beyond STELARA could lift a huge weight off its shoulders and trigger a meaningful price breakout. Add in a solid 3.07% dividend yield, and there's a compelling case to be made: Johnson & Johnson offers a lot of value at a very reasonable price.
Korea Herald
16-06-2025
- Business
- Korea Herald
Celltrion announces U.S. FDA approval of additional presentation of STEQEYMA® (ustekinumab-stba), expanding dosing options for pediatric patients
INCHEON, South Korea, June 16, 2025 /PRNewswire/ -- Celltrion, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved a new presentation of STEQEYMA ® (ustekinumab-stba), a biosimilar to STELARA ® (ustekinumab), in a 45mg/0.5mL solution in a single-dose vial for subcutaneous injection. The additional presentation is approved for the treatment of pediatric patients aged 6 to 17 years, weighing less than 60kg, with plaque psoriasis (PsO) or psoriatic arthritis (PsA). [1] With this approval, STEQEYMA now offers all dosage forms and strengths of its reference product, providing flexibility to meet physicians' clinical needs while supporting treatment continuity for patients. In December 2024, the FDA approved STEQEYMA in 45mg/0.5mL and 90mg/mL solutions in a single-dose prefilled syringe for subcutaneous injection, and 130mg/26mL in a single-dose vial for intravenous infusion in adult and pediatric patients 6 years and older with plaque psoriasis and psoriatic arthritis, as well as adult patients with Crohn's disease and ulcerative colitis. "Managing inflammatory diseases in pediatric patients can be particularly complex," said Hetal Patel, PharmD MBA, Vice President of Medical Affairs at Celltrion USA. "The new dosage form and strength of STEQEYMA allow us to better meet the specific needs of young patients, giving physicians a valuable treatment option with flexibility, supported by a well-established safety and efficacy profile." "We are proud to offer a new presentation of STEQEYMA that aligns with the indications of the reference product," said Thomas Nusbickel, Chief Commercial Officer at Celltrion USA. "This approval reinforces our commitment to broadening access for all patient populations, including children aged 6 years and older living with chronic inflammatory conditions. As a company with a strong legacy in immunology, we are dedicated to ensuring broader access and flexibility in care for patients of all ages." The FDA approval of STEQEYMA was based on the totality of evidence, including the results from a phase III study in adults with moderate to severe plaque psoriasis, in which the primary endpoint was the rate of change in the Psoriasis Area and Severity Index (PASI) for skin symptoms. The clinical results demonstrated that STEQEYMA and its reference product, ustekinumab, are highly similar, and have no clinically meaningful differences in terms of safety and efficacy. [2], [3] The FDA has granted STEQEYMA full interchangeability with STELARA across all indications of STELARA, following the expiration of exclusivity for the first interchangeable biosimilar on April 30, 2025. Notes to Editors: About STEQEYMA ® (ustekinumab-stba) STEQEYMA ®, formerly known as CT-P43, is a human IL-12 and -23 antagonist indicated for multiple immune-mediated diseases. It encompasses all indications approved for the STELARA ® reference product, including psoriasis (PsO), psoriatic arthritis (PsA), Crohn's disease (CD), ulcerative colitis (UC) in adults, and PsO and PsA in pediatric patients 6 years of age and older. STEQEYMA is available in both subcutaneous and intravenous formulations. The subcutaneous injection comes in 45mg/0.5 mL or 90mg/1 mL solution in a single-dose, prefilled syringe and 45mg/0.5mL solution in a single-dose vial. The intravenous infusion is provided as a 130mg/26 mL (5mg/mL) solution in a single-dose vial. INDICATIONS IMPORTANT SAFETY INFORMATION For more information, see Full Prescribing 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 our social media: 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.
Yahoo
15-06-2025
- Business
- Yahoo
Celltrion announces U.S. FDA approval of additional presentation of STEQEYMA® (ustekinumab-stba), expanding dosing options for pediatric patients
Approval of 45mg/0.5mL solution in a single-dose vial for subcutaneous injection expands dosing flexibility for pediatric patients with plaque psoriasis (PsO) or psoriatic arthritis (PsA) under 60kg The FDA previously approved STEQEYMA® 45mg/0.5mL, 90mg/mL in a single-dose prefilled syringe for subcutaneous injection, and 130mg/26mL in a single-dose vial for intravenous infusion in December 2024 STEQEYMA now matches all dosage forms and strengths of its reference product, STELARA® INCHEON, South Korea, June 15, 2025 /PRNewswire/ -- Celltrion, Inc. today announced that the U.S. Food and Drug Administration (FDA) has approved a new presentation of STEQEYMA® (ustekinumab-stba), a biosimilar to STELARA® (ustekinumab), in a 45mg/0.5mL solution in a single-dose vial for subcutaneous injection. The additional presentation is approved for the treatment of pediatric patients aged 6 to 17 years, weighing less than 60kg, with plaque psoriasis (PsO) or psoriatic arthritis (PsA).[1] With this approval, STEQEYMA now offers all dosage forms and strengths of its reference product, providing flexibility to meet physicians' clinical needs while supporting treatment continuity for patients. In December 2024, the FDA approved STEQEYMA in 45mg/0.5mL and 90mg/mL solutions in a single-dose prefilled syringe for subcutaneous injection, and 130mg/26mL in a single-dose vial for intravenous infusion in adult and pediatric patients 6 years and older with plaque psoriasis and psoriatic arthritis, as well as adult patients with Crohn's disease and ulcerative colitis. "Managing inflammatory diseases in pediatric patients can be particularly complex," said Hetal Patel, PharmD MBA, Vice President of Medical Affairs at Celltrion USA. "The new dosage form and strength of STEQEYMA allow us to better meet the specific needs of young patients, giving physicians a valuable treatment option with flexibility, supported by a well-established safety and efficacy profile." "We are proud to offer a new presentation of STEQEYMA that aligns with the indications of the reference product," said Thomas Nusbickel, Chief Commercial Officer at Celltrion USA. "This approval reinforces our commitment to broadening access for all patient populations, including children aged 6 years and older living with chronic inflammatory conditions. As a company with a strong legacy in immunology, we are dedicated to ensuring broader access and flexibility in care for patients of all ages." The FDA approval of STEQEYMA was based on the totality of evidence, including the results from a phase III study in adults with moderate to severe plaque psoriasis, in which the primary endpoint was the rate of change in the Psoriasis Area and Severity Index (PASI) for skin symptoms. The clinical results demonstrated that STEQEYMA and its reference product, ustekinumab, are highly similar, and have no clinically meaningful differences in terms of safety and efficacy.[2],[3] The FDA has granted STEQEYMA full interchangeability with STELARA across all indications of STELARA, following the expiration of exclusivity for the first interchangeable biosimilar on April 30, 2025. Notes to Editors: About STEQEYMA® (ustekinumab-stba) STEQEYMA®, formerly known as CT-P43, is a human IL-12 and -23 antagonist indicated for multiple immune-mediated diseases. It encompasses all indications approved for the STELARA® reference product, including psoriasis (PsO), psoriatic arthritis (PsA), Crohn's disease (CD), ulcerative colitis (UC) in adults, and PsO and PsA in pediatric patients 6 years of age and older. STEQEYMA is available in both subcutaneous and intravenous formulations. The subcutaneous injection comes in 45mg/0.5 mL or 90mg/1 mL solution in a single-dose, prefilled syringe and 45mg/0.5mL solution in a single-dose vial. The intravenous infusion is provided as a 130mg/26 mL (5mg/mL) solution in a single-dose vial. INDICATIONS STEQEYMA® (ustekinumab-stba) is indicated for the treatment of: Plaque Psoriasis (PsO) in adults and pediatric patients 6 years of age and older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. Psoriatic Arthritis (PsA) in adults and pediatric patients 6 years of age and older with active psoriatic arthritis. Crohn's Disease (CD) in adult patients with moderately to severely active Crohn's disease. Ulcerative Colitis (UC) in adult patients with moderately to severely active ulcerative colitis. IMPORTANT SAFETY INFORMATION STEQEYMA is contraindicated in patients with clinically significant hypersensitivity to ustekinumab products or to any of the excipients in STEQEYMA Serious infections have occurred. Avoid starting STEQEYMA during any clinically important active infection. If a serious or clinically significant infection develop, discontinue STEQEYMA until the infection resolves. Serious infections from mycobacteria, salmonella, and BCG vaccinations have been reported in patients genetically deficient in IL-12/IL-23. Consider diagnostic tests for these infections as dictated by clinical circumstances. Evaluate patients for TB prior to starting STEQEYMA. Initiate treatment of latent TB before administering STEQEYMA. Ustekinumab products may increase risk of malignancy. The safety of ustekinumab products in patients with a history of or a known malignancy has not been evaluated. Monitor all patients receiving STEQEYMA for signs of malignancies. If an anaphylactic or other clinically significant hypersensitivity reaction occurs, institute appropriate therapy and discontinue STEQEYMA. If Posterior Reversible Encephalopathy Syndrome (PRES) is suspected, treat promptly, and discontinue STEQEYMA. Avoid use of live vaccines in patients during treatment with STEQEYMA. Non-live vaccinations received during STEQEYMA treatment may not elicit enough immune response to prevent disease. If diagnosis of noninfectious pneumonia is confirmed, discontinue STEQEYMA and institute appropriate treatment. The most common adverse reactions (≥3%) reported in patients receiving ustekinumab were: Psoriasis: nasopharyngitis, upper respiratory tract infection, headache, and fatigue. CD: vomiting, nasopharyngitis, injection site erythema, vulvovaginal candidiasis/mycotic infection, bronchitis, pruritus, urinary tract infection, and sinusitis. UC: nasopharyngitis, headache, abdominal pain, influenza, fever, diarrhea, sinusitis, fatigue, and nausea. For more information, see Full Prescribing Information. About 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 USACelltrion 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 our social media: 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 STELARA® is a registered trademark of Johnson & is a registered trademark of Celltrion, Inc., used under license. References [1] STEQEYMA U.S. prescribing information (2025) [2] Papp KA et al., Efficacy and Safety of Candidate Biosimilar CT-P43 Versus Originator Ustekinumab in Moderate to Severe Plaque Psoriasis: 28-Week Results of a Randomised, Active-Controlled, Double-Blind, Phase III study. BioDrugs. 2023; Online ahead of print. Available at: [Last accessed June 2025] [3] Papp K et al., Efficacy and Safety after Switch from Reference Ustekinumab to Ustekinumab Biosimilar (CT-P43) in comparison with the Maintenance Group (CTP43 or Reference Ustekinumab) in Patients with Moderate-to-Severe Plaque Psoriasis: 1-Year Result. [EADV 2023, Abstract #4035]. Available at: [Last accessed June 2025] For further information please contact:Andria Arenaaarena@ 516-578-0057 View original content to download multimedia: SOURCE Celltrion
