Biosimilar Development News
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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
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Dr. Reddy's Laboratories Launches Versavo (bevacizumab) In The UK
3/19/2024
Dr. Reddy’s Laboratories Ltd. hereafter referred to as “Dr. Reddy’s”), a global pharmaceutical company, announced the launch of Versavo (bevacizumab) in the United Kingdom (UK). Dr. Reddy’s Versavo is a (bevacizumab) biosimilar of Avastin1 and indicated for the treatment of several types of cancers, including metastatic colorectal cancer, advanced non-squamous non-small cell lung cancer, recurrent glioblastoma, metastatic renal cell carcinoma, advanced cervical cancer, ovarian cancer and
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Fresenius Kabi And Formycon Reach Settlement Agreement For Ustekinumab Biosimilar Candidate
3/18/2024
Fresenius Kabi and Formycon announced today that they have reached a settlement agreement with Johnson & Johnson for FYB202, a proposed ustekinumab biosimilar to Stelara in Europe and Canada. The terms of the settlement are confidential.