Accord Healthcare, Inc.

Denosumab marks Accord's sixth biosimilar approval in Europe. The CHMP has issued a positive opinion for Denosumab, to be marketed as Osvyrti® and Jubereq®. Osvyrti® is Accord's second osteoporosis biosimilar, following Sondelbay®. The CHMP's endorsement paves the way for market authorization, with Accord set to launch Denosumab following patent expiry in November 2025 of the brand originator Prolia and Xgeva (Amgen denosumab brands). LONDON, April 2, 2025 /PRNewswire/ -- Accord Healthcare Limited (Accord) is pleased to announce that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for Denosumab, including its branded formulations Osvyrti® and Jubereq®, across its autoimmune and oncology therapy areas. Product Indications Osvyrti® – Bone / Osteoporosis (60mg Pre-Filled Syringe) Indicated for the treatment of osteoporosis in postmenopausal women and men at increased risk of fractures. Denosumab has been shown to significantly reduce the risk of vertebral, non-vertebral, and hip fractures. Indicated for the treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures, reducing the likelihood of vertebral fractures. Indicated for the treatment of bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture. Jubereq® – Oncology (120mg Vial) Indicated for the prevention of skeletal-related events (including pathological fractures, radiation to bone, spinal cord compression, or bone surgery) in adults with advanced malignancies involving bone. Indicated for the treatment of adults and skeletally mature adolescents with giant cell tumour of bone that is unresectable or where surgical resection would likely result in severe morbidity. Joe Dunford, Accord's Vice President of Specialty Brands, commented: "At Accord, we are dedicated to transforming patients' lives, and the recent CHMP approval of these vital medicines is a significant milestone. Osvyrti® enhances our bone health portfolio, joining Sondelbay®, our previously launched teriparatide biosimilar. Additionally, Jubereq® expands our oncology product portfolio and underscores our commitment to advancing our specialty business and driving innovation in oncology - a field in which we have a rich heritage. As a market leader in oncology, we offer over 54 oncology and oncology-related treatments, including small molecule generics, biosimilars, and new chemical entities. This makes us one of the largest suppliers of chemotherapy products in Europe." About Accord Healthcare Headquartered in the United Kingdom (UK), Accord Healthcare, Ltd. is one of the fastest growing pharmaceutical companies in Europe. Accord has one of the largest market footprints among European companies in its category ensuring that over 95% of European patients get access to vital medicines. Accord has over 54 oncology and oncology-related treatments making it one of the largest suppliers of chemotherapy products in Europe with an additional 20 treatments which are currently in development and scheduled for launch over the next 5 years. Our approach is agile and inventive, always seeking to improve our products and patients' access to them. We're driven to think differently and deliver more for the benefit of patients worldwide. Logo - WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

For Eisai and Biogen, the European Medicines Agency’s Committee for Medicinal Products for Human Use’s decision to stick by its previous call on Leqembi now punts the final approval verdict back to the European Commission, which is the ultimate authority on whether a drug scores marketing authorization in the EU. Following a flurry of activity at this month’s meeting of the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP), drugmakers are celebrating a bevy of endorsements for big-name meds.Over the course of the sit-down, which ran from Monday through Thursday, the CHMP recommended four new drugs for approval, teed up another 16 potential label expansions and—in a major win for Eisai and Biogen—reaffirmed the positive opinion on the Alzheimer’s disease drug Leqembi (lecanemab) it first issued in November, according to the agency’s meeting summary Friday.For Eisai and Biogen, the CHMP’s decision to stick by its previous call now punts the final approval verdict for Leqembi back to the European Commission (EC), which is the ultimate authority on whether a drug scores marketing authorization in the EU.Despite Leqembi winning the CHMP’s favor in November—albeit in a somewhat restricted patient population—the European regulator last month said it would honor the EC’s request to consider new safety data on the antibody that surfaced after the initial thumbs-up, Biogen explained in a Friday press release.“The safety profile of lecanemab reported in clinical practice in the United States, Japan and other countries after launch is consistent with that in the approved labels, and no new safety signals are identified,” Biogen said of the situation last month. The CHMP has specifically backed Leqembi to treat mild cognitive impairment or mild dementia from Alzheimer’s but only for patients carrying one or no copy of the ApoE4 gene. Patients with two copies of the gene are at greater risk of brain swelling or bleeding side effects known as amyloid-related imaging abnormalities, according to trial data. Elsewhere, the CHMP this week advanced four new drugs for potential European approvals. Those are: Takeda’s immunoglobulin drug Deqsiga, Regeneron’s multiple myeloma antibody Lynozyfic, Krystal Biotech’s dystrophic epidermolysis bullosa gene therapy Vyjuvek and Accord Healthcare’s generic drug trabectedin, which has been endorsed in advanced soft tissue sarcoma and relapsed platinum-sensitive ovarian cancer.As for proposed label expansions, the CHMP endorsed new uses for drugs from Vertex, Novartis, AbbVie, Eli Lilly and many other companies.In Lilly’s case, the regulator recommended approval for the company’s BTK inhibitor Jaypirca to treat adults with relapsed or refractory chronic lymphocytic leukemia (CLL) who’ve already tried another medication from the same class.In addition to the new positive opinion in CLL, the drug also boasts a conditional European nod in mantle cell lymphoma, Lilly noted in a press release.AbbVie, for its part, got the CHMP’s backing in its bid to expand Rinvoq’s reach into the inflammatory disease giant cell arteritis, while Novartis’ Fabhalta received the agency’s blessing to treat adults with C3 glomerulopathy (C3G). C3G is an ultrarare kidney disease—often striking when people are young—that currently lacks any approved treatment options, Novartis said Friday.Other major label expansions that passed muster with the CHMP include those for Vertex’s Kaftrio and Kalydeco in combination to treat cystic fibrosis patients 2 and older who have at least one non-class I mutation in the cystic fibrosis transmembrane conductance regulator gene, plus a bid to expand the use of Valneva’s chikungunya vaccine Ixchiq to provide active immunization for kids starting at age 12. Notably, several drugmakers withdrew applications from the CHMP.Sanofi, for example, pulled the plug on efforts to score a European label expansion for Dupixent to treat moderate to severe chronic spontaneous urticaria in adults and adolescents, according to the committee's update. Plus, Spanish biotech HIPRA withdrew the application for an adapted version of its COVID-19 vaccine Bimervax targeting an updated strain of the SARS-CoV-2 virus. 

The European Medicines Agency’s human medicines committee (CHMP) has recommended four new drugs for approval, including Regeneron’s Lynozyfic for the treatment of relapsed and refractory multiple myeloma. The recommendation is a step forward for Regeneron in Europe after the FDA last August rejected its drug in the US over manufacturing issues . The FDA has set a new decision deadline of July 10. CHMP also suggested that the European Commission approve Krystal Biotech’s Vyjuvek for the treatment of wounds in patients with dystrophic epidermolysis bullosa, a genetic skin condition. The other recommendations were for Accord Healthcare’s generic trabectedin and Takeda’s immunoglobulin drug Deqsiga. The European Commission has the final authority over new drug approvals, but it typically follows CHMP’s recommendations. CHMP also recommended 16 label expansions, including Novartis’ Fabhalta for the treatment of rare kidney disease C3 glomerulopathy (C3G), which currently has no approved medicines. Fabhalta is currently approved by the EMA as a treatment for hemolytic anemia in patients with a blood disease called paroxysmal nocturnal hemoglobinuria. The FDA is reviewing Fabhalta for C3G, with a decision date expected by June . The agency was supposed to hold a meeting for the kidney drug this week but it was canceled for unknown reasons . CHMP said that no changes need to be made to Eisai and Biogen’s Alzheimer’s drug Leqembi, after the commission had requested a review of the drug’s market authorization in January. A review was requested after CHMP gave a positive opinion on the drug to treat Alzheimer’s patients with only one or no copy of the ApoE4 gene in November 2024. CHMP had previously rejected Leqembi in July 2024. CHMP’s other label expansion recommendations include: