Biosimilar Development News
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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).
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Phase 3 Comparative Clinical Study Of Prolia And Xgeva (denosumab) Biosimilar Candidate HLX14 Met Primary Endpoints
4/8/2024
Shanghai Henlius Biotech, Inc. and Organon announced that the phase 3 comparative clinical trial for the investigational Prolia and Xgeva (denosumab) biosimilar HLX14 met the primary endpoints.
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Samsung Bioepis Initiates Phase 3 Clinical Trial For SB27, Proposed Biosimilar To Keytruda (Pembrolizumab)
4/5/2024
Samsung Bioepis Co., Ltd. today announced the initiation of Phase 3 clinical trial for SB27, the company's proposed biosimilar referencing Keytrudai (pembrolizumab).
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Teva And mAbxience Announce Strategic Global Licensing Agreement For Oncology Biosimilar Candidate
4/4/2024
Teva Pharmaceuticals International GmbH, a subsidiary of Teva Pharmaceutical Industries Ltd. and mAbxience, a Fresenius Kabi majority-owned group with partial ownership from Insud Pharma, today announced they have entered a strategic licensing agreement for a biosimilar candidate currently in development for the treatment of multiple oncology indications.
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NeoImmuneTech Appoints Dr. Luke Oh, Ph.D. As New Chief Executive Officer
4/2/2024
NeoImmuneTech, Inc. (KOSDAQ: 950220), announced that Luke Oh, Ph.D. has been appointed as President and Chief Executive Officer (CEO) of NeoImmuneTech, Inc. (NIT or "NeoImmuneTech"), effective from March 29, 2024 (EDT).
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Biosimilars Forum Announces Support For Increasing Access To Biosimilars Act
3/20/2024
Bipartisan legislation introduced by U.S. Senators John Cornyn (R-TX) and Michael Bennet (D-CO) would lower prescription drug prices for seniors and promote free-market competition