Biosimilar Development News

  1. Accord BioPharma's HERCESSI™ (trastuzumab-strf) Gains Preferred Status On Express Scripts National Commercial Formularies 1/5/2026

    Accord BioPharma Inc., the specialty division of Intas Pharmaceuticals, Ltd., focused on the development of oncology, immunology, and critical care therapies, announced that Express Scripts, one of the nation's largest pharmacy benefit managers, has added HERCESSI™ (trastuzumab-strf) to preferred status on its largest commercial formularies, including National Preferred Formulary, effective January 1, 2026.

  2. CivicaScript Announces Availability Of Low-Cost Insulin And Biosimilar For Chronic Inflammatory Conditions In The US 1/5/2026

    CivicaScript®, LLC, a nonprofit company dedicated to bringing low-cost generic medicines and biosimilars to U.S. patients, today announced the availability of two new products: insulin glargine-yfgn and ustekinumab-aauz.

  3. Samsung Bioepis Begins Commercialization Of BYOOVIZ, Biosimilar To Lucentis (Ranibizumab), In Europe 1/2/2026

    Samsung Bioepis Co., Ltd. today announced that the company has begun direct commercialization of BYOOVIZ, a biosimilar to Lucentis1 (ranibizumab), in Europe.

  4. Alvotech Secures Term Loan Facility Of USD 100 Million 12/31/2025

    Alvotech (NASDAQ: ALVO), a global biotechnology company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced a USD 100 million senior term loan facility with maturity in December 2027 aimed at strengthening liquidity and supporting the execution of Alvotech’s strategic priorities in 2026.

  5. 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).

  6. 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.

  7. 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).

  8. 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.

  9. 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.

  10. Samsung Bioepis Announces Approval Of Ustekinumab Biosimilar In Japan 12/22/2025

    Samsung Bioepis Co., Ltd. today announced the marketing approval of Ustekinumab BS Subcutaneous Injection 45mg Syringes 'NIPRO', a biosimilar referencing Stelara1 (ustekinumab), developed by Samsung Bioepis. This is the first product to gain marketing approval in Japan under the partnership with NIPRO CORPORATION entered in June 2025.