Latest news with #denosumab
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Business Standard
5 days ago
- Business
- Business Standard
Biocon shares slip 3% as Q1 results miss estimates; should you sell?
Shares of Biocon fell over 3 per cent on Monday after the company reported a 95.2 per cent year-on-year (Y-o-Y) decline in net profit in the first quarter of the current financial year (Q1FY26). The biopharma company's stock fell as much as 3.60 per cent during the day to ₹331 per share, the lowest level since June 6 this year. The stock pared losses to trade 0.9 per cent higher at ₹340.4 apiece, compared to a 0.22 per cent advance in Nifty 50 as of 11:45 AM. Shares of the company fell for the second straight day and currently trade at 1.5 times the average 30-day trading volume, according to Bloomberg. The counter has fallen 7.2 per cent this year, compared to a 3.3 per cent advance in the benchmark Nifty 50. Biocon has a total market capitalisation of ₹45,349.81 crore. Biocon Q1 results The Bengaluru-based company reported a 95.2 per cent Y-o-Y drop in consolidated net profit at ₹31 crore in Q1FY26, compared to ₹660 crore in the same period last year. The Q1 FY25 profit included a one-time divestment gain, impacting this year's base. The firm's revenue rose 15 per cent to ₹4,022 crore on a like-for-like basis after adjusting for the one-time gain in the base quarter. Operating revenue increased 15 per cent to ₹3,942 crore in Q1 FY26, up from ₹3,433 crore in Q1 FY25. The generics business reported revenue of ₹697 crore, a 6 per cent Y-o-Y increase, while the CRDMO business, Syngene, reported revenue of ₹875 crore, up 11 per cent Y-o-Y. 'Biocon opened FY26 with a strong performance, driven by continued gains in biosimilars and CRDMO, and a steady showing in generics. The recent QIP has strengthened our balance sheet and enabled us to increase our ownership in Biocon Biologics by facilitating the exit of structured equity investors, aligning capital structure with long-term strategic priorities,' said Kiran Mazumdar-Shaw, chairperson, Biocon Group. Analysts in Biocon earnings Nuvama Institutional Equities said Biocon's Q1FY26 revenue and Ebitda missed consensus estimates by 2 per cent and 11 per cent, respectively, due to weakness in the generics segment. The brokerage noted market share gains in key biosimilar products, steady margins, and upcoming launches of bAspart, denosumab, bevacizumab, and bEylea as positive signs. However, it said execution will be critical to achieving high growth, with the generics segment still dragging and consistent margin delivery yet to be demonstrated amid elevated costs from new facilities. Nuvama maintained its 'Hold' rating on the stock, with a revised target price of ₹365, up from ₹345 earlier. Motilal Oswal said Biocon's Q1FY26 financial performance came in below expectations, primarily due to a sharp decline in generics sales and higher operating expenses. The brokerage noted that Biocon is building growth levers across its generics, biologics, and Syngene businesses, with an encouraging product pipeline in both generics and biologics. It cut its earnings estimates by 7 per cent for FY26 and 3 per cent for FY27, while maintaining a 'Buy' rating with a target price of ₹410.
Yahoo
08-07-2025
- Health
- Yahoo
Celltrion USA announces U.S. launch of denosumab biosimilars, STOBOCLO® and OSENVELT® (denosumab-bmwo)
STOBOCLO® (denosumab-bmwo) and OSENVELT® (denosumab-bmwo) are approved by FDA for all indications of PROLIA® (denosumab) and XGEVA® (denosumab) respectively[1],[2] STOBOCLO and OSENVELT, among the first wave of biosimilars referencing PROLIA and XGEVA respectively, are commercially available in the U.S. Celltrion further expands its portfolio, delivering cost-effective and high-quality biologic medicines to wider range of patients in the U.S. JERSEY CITY, N.J., July 7, 2025 /PRNewswire/ -- Celltrion USA today announced that STOBOCLO® (denosumab-bmwo) and OSENVELT® (denosumab-bmwo), biosimilars referencing PROLIA® (denosumab) and XGEVA® (denosumab) respectively, are commercially available in the United States. STOBOCLO is available in 60 mg/mL injection and is approved to treat postmenopausal women with osteoporosis at high risk for fracture, to increase bone mass in men with osteoporosis at high risk for fracture, to treat glucocorticoid-induced osteoporosis in men and women at high risk for fracture, to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer, and to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer.[1] OSENVELT is available in 120 mg/1.7 mL (70 mg/mL) injection and is indicated to prevent skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors, to treat adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity, and to treat hypercalcemia of malignancy refractory to bisphosphonate therapy.[2] "We are pleased to have achieved a global settlement with Amgen regarding our denosumab biosimilars," said Thomas Nusbickel, Chief Commercial Officer at Celltrion USA. "We are proud to introduce our denosumab biosimilars to the U.S. market, offering patients and healthcare professionals a valuable alternative treatment option. Building on our strong heritage in biosimilars, Celltrion remains committed to being a trusted partner for both patients and physicians, while contributing to the overall sustainability of healthcare systems." STOBOCLO and OSENVELT are supported by Celltrion's comprehensive patient support programs designed to help empower patients to navigate their treatment journeys. Celltrion offers a suite of resources, including the Celltrion CONNECT® Patient Support Program and the Celltrion CARES™ Co-pay Assistance Program. Patients who are uninsured may be able to receive STOBOCLO and OSENVELT at no cost. Visit and to learn more. Celltrion's biosimilars portfolio covers the areas of immunology, oncology, gastroenterology, allergy, and endocrinology. About STOBOCLO® (denosumab-bmwo) STOBOCLO® (denosumab-bmwo) is a receptor activator of NF-κb ligand (RANKL) inhibitor referencing PROLIA® (denosumab). STOBOCLO 60 mg/mL injection is approved by the FDA based on comprehensive data and clinical evidence confirming the therapeutic equivalence to PROLIA. In the U.S., STOBOCLO is approved to treat postmenopausal women with osteoporosis at high risk for fracture, to increase bone mass in men with osteoporosis at high risk for fracture, to treat glucocorticoid-induced osteoporosis in men and women at high risk for fracture, to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer, and to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer. INDICATIONS STOBOCLO® (denosumab-bmwo) is a RANK ligand (RANKL) inhibitor indicated for treatment: of postmenopausal women with osteoporosis at high risk for fracture to increase bone mass in men with osteoporosis at high risk for fracture or in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer of glucocorticoid-induced osteoporosis in men and women at high risk for fracture to increase bone mass in women at high risk for fracture receiving an adjuvant aromatase inhibitor therapy for breast cancer IMPORTANT SAFETY INFORMATION WARNING: SEVERE HYPOCALCEMIA IN PATIENTS WITH ADVANCED KIDNEY DISEASE Patients with advanced chronic kidney disease, including those on dialysis, face a higher risk of severe hypocalcemia after denosumab administration, with reported cases leading to hospitalization, life-threatening events, and fatalities. The presence of chronic kidney disease-mineral bone disorder (CKD-MBD) markedly increases the risk of hypocalcemia in these patients Before starting STOBOCLO® (denosumab-bmwo) in advanced chronic kidney disease patients, assess for CKD-MBD. Treatment should be supervised by a healthcare provider experienced in diagnosing and managing CKD-MBD. STOBOCLO is contraindicated in hypocalcemia, pregnant women, and in patients with known hypersensitivity to denosumab. Severe Hypocalcemia: Ensure adequate calcium and vitamin D; monitor for severe hypocalcemia. Drug Products with Same Active Ingredient: Do not use with other denosumab products. Hypersensitivity: If an anaphylactic or other clinically significant allergic reaction occurs, initiate appropriate therapy and discontinue further use of STOBOCLO. Osteonecrosis of the Jaw (ONJ): ONJ can occur in patients on STOBOCLO. Conduct oral exams before treatment; maintain oral hygiene; consider discontinuation of STOBOCLO if ONJ develops. Atypical Subtrochanteric and Diaphyseal Femoral Fractures: Monitor for thigh, hip, or groin pain; evaluate for fractures. Interruption of STOBOCLO therapy should be considered, pending a benefit-risk assessment, on an individual basis. Multiple Vertebral Fractures (MVF) Following Discontinuation of Treatment: Increased risk post-discontinuation of denosumab; transition to alternative therapy if discontinuing STOBOCLO. Serious Infections: Higher risk in denosumab users; assess benefit-risk profile, especially in immunocompromised patients. Assess the benefit-risk profile before starting STOBOCLO and reconsider its use if serious infections develop. Dermatologic Adverse Reactions: Consider discontinuing STOBOCLO if severe dermatitis, eczema, or rashes occur. Musculoskeletal Pain: Consider discontinuation of STOBOCLO if severe pain develops. Bone Turnover Suppression: In clinical trials in women with postmenopausal osteoporosis, denosumab significantly suppressed bone remodelling; patients should be monitored for these outcomes. Hypercalcemia in Pediatrics Patients with Osteogenesis Imperfecta: Not for pediatric use; hypercalcemia reported in patients osteogenesis imperfecta treated with denosumab products. Most common Adverse Reactions: In (>5%) of patients with: Postmenopausal osteoporosis were back pain, pain in extremity, hypercholesterolemia, musculoskeletal pain, and cystitis. Pancreatitis has been reported in clinical trials. Male osteoporosis were back pain, arthralgia, and nasopharyngitis. Glucocorticoid-induced osteoporosis (> 3%) were back pain, hypertension, bronchitis, and headache. Bone loss due to hormone ablation for cancer (≥ 10%) were arthralgia and back pain. Pain in extremity and musculoskeletal pain have also been reported in clinical trials. For more information, see Full Prescribing Information. About OSENVELT® (denosumab-bmwo) OSENVELT® (denosumab-bmwo) is a receptor activator of NF-κb ligand (RANKL) inhibitor referencing XGEVA® (denosumab). OSENVELT 120 mg/1.7 mL (70 mg/mL) injection is approved by the FDA based on a robust clinical trial and comprehensive data confirming the therapeutic equivalence to XGEVA. In the U.S., OSENVELT is indicated to prevent skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors, to treat adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity, and to treat hypercalcemia of malignancy refractory to bisphosphonate therapy. INDICATION OSENVELT® (denosumab-bmwo) is indicated for: Prevention of skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors. Treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity. Treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy. IMPORTANT SAFETY INFORMATION Contraindications: Patients with hypocalcemia or with known clinically significant hypersensitivity to denosumab products. Drug Products with Same Active Ingredient. Patients receiving OSENVELT should not receive other denosumab products concomitantly. Hypersensitivity. If an anaphylactic or other clinically significant allergic reaction occurs, initiate appropriate therapy and discontinue further use of OSENVELT. Hypocalcemia. Severe hypocalcemia can occur, and fatal cases have been reported. Monitor calcium levels and calcium and vitamin D intake. Osteonecrosis of the Jaw (ONJ): ONJ can occur in patients on OSENVELT. Conduct oral exams and appropriate preventive dentistry before and during treatment; maintain oral hygiene and avoid invasive dental procedures; consider discontinuation of OSENVELT if ONJ develops. Atypical Subtrochanteric and Diaphyseal Femoral Fractures: Monitor for thigh, hip, or groin pain; evaluate for fractures. Interruption of OSENVELT therapy should be considered, pending a benefit-risk assessment, on an individual basis. Hypercalcemia Following Treatment Discontinuation in Patients with Giant Cell Tumor of Bone and in Patients with Growing Skeletons. Clinically significant hypercalcemia, potentially requiring hospitalization, can occur within a year after stopping denosumab in patients with giant cell tumor of bone or growing skeletons; monitor serum calcium and manage calcium and vitamin D needs post-discontinuation. Multiple Vertebral Fractures (MVF) Following Treatment Discontinuation. Increased risk post-discontinuation of denosumab; evaluate for risk for vertebral fractures after discontinuing OSENVELT. Embryo-Fetal Toxicity. Denosumab may cause fetal harm; verify pregnancy status before starting OSENVELT and advise effective contraception during treatment and for 5 months after the last dose. Most common Adverse Reactions: Bone Metastasis from Solid Tumors (≥ 25%) were fatigue/asthenia, hypophosphatemia, and nausea. In patients (≥ 10%) with: Multiple Myeloma were diarrhea, nausea, anemia, back pain, thrombocytopenia, peripheral edema, hypocalcemia, upper respiratory tract infection, rash, and headache; Giant Cell Tumor of Bone were arthralgia, headache, nausea, back pain, fatigue, and pain in extremity. Hypercalcemia of Malignancy (> 20%) were nausea, dyspnea, decreased appetite, headache, peripheral edema, vomiting, anemia, constipation, and diarrhea. 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. 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", 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 to 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 STOBOCLO® and OSENVELT® are registered trademarks of Celltrion, and XGEVA® are registered trademarks of Amgen Inc. References [1] STOBOCLO U.S. prescribing information (2025) [2] OSENVELT U.S. prescribing information (2025) US-CT-P41-25-00006 For further information please contact:Andria Arenaaarena@ 516-578-0057 View original content to download multimedia: SOURCE Celltrion 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
02-07-2025
- Business
- Yahoo
mAbxience Announces European Commission Approval of Denosumab Biosimilars
MADRID, July 2, 2025 /PRNewswire/ -- mAbxience, a Fresenius Kabi majority-owned group with partial ownership from Insud Pharma, is pleased to announce that the European Commission has granted approval for its denosumab biosimilars Denbrayce® and Izamby®. This approval follows a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) and represents a major milestone in mAbxience's mission to provide high-quality, accessible, and affordable therapies worldwide. Denbrayce®, referencing Amgen's Xgeva®, is indicated for the prevention of skeletal-related events in adults with advanced malignancies involving bone, as well as for the treatment of adults and skeletally mature adolescents with giant cell tumor of bone. Izamby®, referencing Amgen's Prolia®, is indicated for the treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures, a condition that causes bones to become weak and more prone to breaking. "This approval is a testament to mAbxience's dedication to scientific excellence and our commitment to broadening access to essential biologic therapies," said Jurgen Van Broeck, CEO of mAbxience. "We are proud to contribute to reducing the burden of osteoporosis, cancer-related bone conditions, and rare bone diseases in Europe. This milestone brings us one step closer to ensuring that more patients across Europe can benefit from high-quality, affordable treatment options." Denosumab is a human monoclonal antibody that works by inhibiting the receptor activator of nuclear factor kappa-B ligand (RANKL), thereby preventing the development of osteoclasts, the cells responsible for bone breakdown. It is a well-established treatment for osteoporosis, treatment-induced bone loss, bone metastases, and giant cell tumor of bone. With the approval of these biosimilars mAbxience further demonstrates its expertise in the development and production of biosimilars, reinforcing its contribution to improving patient access to life-changing therapies and supporting the sustainability of healthcare systems across Europe. This approval marks another important step in mAbxience's mission to provide affordable, accessible and life-changing therapies worldwide. With a robust pipeline and a growing network of partners, mAbxience continues to enhance patient access to advanced treatments while supporting healthcare systems in managing the rising costs of biologic medicines. About mAbxience mAbxience is a Spanish-based company specializing in the development, production, and commercialization of biopharmaceuticals. In August 2022, Fresenius Kabi and Insud Pharma entered into an agreement whereby Fresenius Kabi, an operating company of Fresenius, acquired a majority stake of mAbxience, making it a global, vertically integrated biotechnology company. With over a decade of expertise, our mission is clear: to provide accessible, affordable medicines across the globe, aiming to enhance the quality of life by ensuring universal access to high-caliber medicines. With two market-approved products and a robust pipeline in development, we have established a B2B presence in over 100 markets. Alongside this, we have formed a network with more than 30 partners and built a dedicated team of over 1,000 professionals. Our three multi-product facilities, located in Europe and South America, have obtained GMP approval from esteemed regulatory bodies, including the FDA, EMA, and others. Furthermore, as a global biopharmaceutical expert, mAbxience specializes in Contract Development and Manufacturing Organization services (CDMO), utilizing advanced technology and innovative platforms to deliver integrated manufacturing solutions. For more insights into mAbxience, our biosimilars and CDMO business, please visit our website ( or connect with us on LinkedIn. Photo: View original content to download multimedia: SOURCE mAbxience 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
16-05-2025
- Business
- Yahoo
FDA biosimilar approvals set for record-breaking year amid US pricing reforms
2024 saw the highest number of biosimilars approved by the US Food and Drug Administration (FDA) in a calendar year, with this year set to break this record again, analysis suggests. The FDA approved 19 biosimilars last year, a sharp jump from the five greenlit by the agency in 2023. GlobalData's Bio/Pharmaceutical Outsourcing Report notes that momentum for biosimilars is set to accelerate. A total of 18 biologics will lose patent protection in 2025, up from 14 in 2024. This includes blockbuster products such as Amgen's Prolia (denosumab) and Roche's Perjeta (pertuzumab). GlobalData, the parent company of Pharmaceutical Technology, states that projections indicate that 2025 could surpass 2024's milestone trend. Debutants in 2024 included Amgen's Wezlana (ustekinumab-auub), the first of six biosimilars to Johnson & Johnson's (J&J's) blockbuster autoimmune drug Stelara (ustekinumab). Stelara generated $10.9bn in 2023, making it one of the top-selling drugs to gain biosimilar competition last year. There were also five new drugs referencing the ophthalmology drug Eylea (aflibercept) that gained FDA approval in 2024. Regeneron's Eylea saw sales of $5.89bn in sales in 2023 before rivals entered the market. It was also a strong 2024 for drugmakers in the space. Sandoz reported that biosimilar sales grew 30%, contributing to the company's $10.4bn net sales. Samsung Bioepis, another biosimilar specialist, posted a record-breaking financial year in 2024, with sales and operating profit up by 51% and 112%, respectively. The spike in approvals is set against a backdrop of governmental pushes to increase reference drug use. US President Donald Trump signed an executive order (EO) earlier this week that overhauled pharmaceutical pricing in the country. According to a Reuters article, pharma companies launched new US drugs at prices 35% higher in 2023, compared to those launched in 2022. Biosimilars and generics can be as much as 80% cheaper than branded alternatives. Kathryn Kinch, senior pharma product manager at GlobalData, said: 'Increased approvals of biosimilars are likely to lower biologic prices, enhancing consumer demand and competition among drug companies, which will benefit contract manufacturing organisations through higher biosimilar volumes.' As per a White House fact sheet, the EO 'increases the availability of generics and biosimilars'. Trump already pushed the FDA to expedite the development of lower-cost generic medicines and biosimilars in his first term as president. Juliana Reed, executive director of the Biosimilars Forum, said: '[We are] pleased to see the Trump Administration announce meaningful action on several fronts, including reforms to make biosimilars available quickly and efficiently to all Americans who need them. The EO also accelerates approval of biosimilars through the FDA and requires transparency and fairness from middlemen who prioritise profits over patients. 'Safe, effective, and lower-cost biosimilars are the clear answer to America's skyrocketing prescription drug costs.' "FDA biosimilar approvals set for record-breaking year amid US pricing reforms" was originally created and published by Pharmaceutical Technology, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site.
