Biosimilar Development News
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Biogen Receives Positive CHMP Opinion For TOFIDENCE™ (tocilizumab), A Biosimilar Referencing ROACTEMRA®
4/25/2024
Biogen Inc. (Nasdaq: BIIB) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion for TOFIDENCE™ (tocilizumab), a biosimilar monoclonal antibody referencing ROACTEMRA®1.
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Evernorth Announces Humira Biosimilar Available At $0 Out Of Pocket For Accredo Patients In June
4/25/2024
In an important step toward driving long-term affordability and access to treatments for chronic and complex conditions, Evernorth Health Services announced that it will have a Humira® biosimilar available for $0 out of pocket for eligible patients of its specialty pharmacy Accredo beginning this June.
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Alvotech Announces Topline Results From A Confirmatory Clinical Study For AVT05, A Proposed Biosimilar For Simponi® (golimumab)
4/24/2024
Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today positive topline results from a confirmatory clinical study for AVT05, Alvotech’s proposed biosimilar to Simponi® and Simponi Aria® (golimumab).
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Samsung Bioepis Gains European Commission Approval For PYZCHIVA7™, A Biosimilar To Stelara (Ustekinumab)
4/22/2024
Samsung Bioepis Co., Ltd. today announced that the European Commission (EC) has granted marketing authorization for PYZCHIVA™, a biosimilar to Stelara1,2 (ustekinumab), paving the way for expanding its immunology portfolio.
- Sandoz Confirms European Commission Approval Of Pyzchiva (ustekinumab), Further Strengthening Immunology Offering 4/22/2024
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Alvotech Signs U.S. Agreement To Expand Access For Newly Approved High-Concentration Interchangeable Biosimilar To Humira® (adalimumab)
4/19/2024
Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today a long-term agreement with a strategic partner to further enhance access to Adalimumab-ryvk in the U.S. market, the newly U.S. Food and Drug Administration (FDA) approved high-concentration interchangeable biosimilar to Humira.
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Alvotech And Teva Announce U.S. FDA Approval Of SELARSDI™ (ustekinumab-aekn), Biosimilar To Stelara® (ustekinumab)
4/16/2024
Alvotech (NASDAQ: ALVO) and Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced that the U.S. Food and Drug Administration (FDA) has approved SELARSDI (ustekinumab-aekn) injection for subcutaneous use, as a biosimilar to Stelara®, for the treatment of moderate to severe plaque psoriasis and for active psoriatic arthritis in adults and pediatric patients 6 years and older.
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Fresenius Accelerates Momentum In Its (Bio)Pharma Business And Launches Tyenne, Its Third Approved Biosimilar In The U.S
4/15/2024
Fresenius, via its operating company Fresenius Kabi, announced today the immediate U.S. availability of Tyenne (tocilizumab-aazg), a biosimilar of Actemra (tocilizumab). Tyenne, for use in the treatment of chronic autoimmune diseases, is available in an intravenous (IV) formulation.
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Boan Biotech Completes Phase 3 Clinical Trial For Its Aflibercept Intravitreous Injection BA9101 In China, Planning To File A BLA
4/8/2024
Boan Biotech today announced that a Phase 3 clinical trial (a comparative study of efficacy and safety) for its Aflibercept Intravitreous Injection (BA9101) in China has been completed.
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MAIWEIJIAN, First Approved Biosimilar Of Denosumab (120mg) In China
4/8/2024
Mabwell (688062.SH), an innovation-driven biopharmaceutical company with entire industry chain, announced that Denosumab Injection (trade name: MAIWEIJIAN, R&D code: 9MW0321) developed by its wholly-owned subsidiary T-mab has officially obtained the marketing authorization approval by National Medical Products Administration (NMPA) (Drug Approval Number: [GYZZ]S20240010).