Biosimilar Development News

  1. Mabwell's Adalimumab Biosimilar Receives Marketing Approval In Indonesia 12/31/2025

    Mabwell (688062.SH), an innovation-driven biopharmaceutical company with a fully integrated industry chain, announced that its Adalimumab Injection 9MW0113 (Marketed as JUNMAIKANG in China) has been granted marketing authorization by the Indonesian Food and Drug Authority (Badan Pengawas Obat dan Makanan, BPOM).

  2. Zydus Partners With Bioeq For U.S. Commercialisation Rights For NUFYMCO®, An Interchangeable Biosimilar To Lucentis® 12/26/2025

    Bioeq AG ("Bioeq"), a Swiss biopharmaceutical company, and Zydus Lifesciences Limited ("Zydus"), an innovation-led life-sciences company with an international presence, today announced that its wholly owned subsidiary, Zydus Lifesciences Global FZE, United Arab Emirates has entered into a strategic partnership with Bioeq, for the licensing, supply and commercialization of Bioeq`s Vascular Endothelial Growth Factor (VEGF) inhibitor NUFYMCO®, an interchangeable biosimilar of Lucentis®1 (Ranibizumab) for the U.S. market.

  3. Biocon Biologics Secures Full Global Rights To Biosimilar Adalimumab Through Expanded FKB In-Licensing Agreement 12/23/2025

    Biocon Biologics Limited, a fully integrated global biosimilars company and subsidiary of Biocon Ltd., today announced that it has secured full and exclusive global rights for Hulio (biosimilar Adalimumab) from Fujifilm Kyowa Kirin Biologics Co., Ltd. (FKB).

  4. FDA Approves Another Interchangeable Ranibizumab Biosimilar, Nufymco – Strengthening US Presence With Zydus As Commercialization Partner 12/23/2025

    Formycon AG (“Formycon”) and Bioeq AG (“Bioeq”) announce that the U.S. Food and Drug Administration (FDA) has approved Nufymco1 (ranibizumab-leyk), an interchangeable biosimilar to Lucentis2. With its second FDA-approved ranibizumab biosimilar in the US, the companies are further underscoring their pioneering position in high-quality biosimilar development.

  5. Alvotech Announces European Launch Of First-In-Market Biosimilar To Simponi® (golimumab) Globally By Partner Advanz Pharma 12/22/2025

    Alvotech (NASDAQ: ALVO), a global biotechnology company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that launches are underway in Europe for Gobivaz® (golimumab), Alvotech’s biosimilar to Simponi® (golimumab), also known as AVT05 (prefilled syringe and autoinjector). Gobivaz is the first marketed biosimilar to Simponi worldwide.

  6. Amneal Announces FDA Approval Of Denosumab Biosimilars Referencing Prolia® And XGEVA® 12/22/2025

    Amneal Pharmaceuticals, Inc. (“Amneal” or the “Company”) (NASDAQ: AMRX) and mAbxience, a Fresenius Kabi majority-owned group with partial ownership from Insud Pharma, today announced that the U.S. Food and Drug Administration (FDA) has approved its Biologics Licensing Applications (BLAs) for Boncresa™ (denosumab-mobz), a biosimilar referencing Prolia®, and Oziltus™ (denosumab-mobz), a biosimilar referencing XGEVA®.

  7. Alvotech And Teva Secure U.S. Settlement Date For AVT06, A Proposed Biosimilar To Eylea® 12/19/2025

    Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, and Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced that they have reached a settlement and license agreement with Regeneron Pharmaceuticals Inc. concerning the launch of AVT06, Alvotech’s proposed biosimilar to Eylea® (aflibercept) in the United States.

  8. Zydus And Formycon Enter Into An Exclusive Partnership For The Licensing And Supply Of Biosimilar To Keytruda® (Pembrolizumab), In US And Canada 12/19/2025

    Zydus Lifesciences Limited (including its subsidiaries and affiliates), an innovation-led life-sciences company, with an international presence, today announced that its wholly owned subsidiary, Zydus Lifesciences Global FZE, United Arab Emirates has entered into a strategic partnership with Formycon AG for the exclusive licensing and supply of checkpoint inhibitor FYB206, a biosimilar of Keytruda®1 (Pembrolizumab) in the USA and Canada market.

  9. Lupin Receives Positive CHMP Opinion For Biosimilar Ranibizumab 12/17/2025

    Global pharma major Lupin Limited (Lupin) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending marketing authorization for its biosimilar ranibizumab, RanluspecTM, for both vial and pre-filled syringe presentations.

  10. Biocon Biologics Signs Settlement And License Agreement To Commercialize Biosimilar Aflibercept Worldwide 12/13/2025

    Biocon Biologics Ltd (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd, announced today a new settlement and license agreement with Regeneron and Bayer for biosimilar Aflibercept (40mg/ml) in Europe and the rest of the world, which follows an earlier settlement covering the United States and Canada.