Biosimilar Development News

  1. Zydus Launches Biosimilar Aflibercept 2 mg ANYRA For Advancing Ophthalmic Care 2/19/2026

    Zydus Lifesciences Ltd., an innovation-led global life sciences company, today announced the launch of Anyra, India’s first indigenously developed biosimilar of Aflibercept 2 mg. Zydus has also signed an agreement with Regeneron Pharmaceuticals, Inc. and Bayer.

  2. Sandoz Receives US FDA Approval To Expand Enzeevu (aflibercept-abzv) Label For Multiple Retinal Indications 2/18/2026

    Sandoz , the global leader in affordable medicines, today announced that the US Food and Drug Administration (FDA) has approved an expanded label for Enzeevu (aflibercept-abzv), to include multiple retinal indications.

  3. FDA Approves FILKRI7™ (filgrastim-laha), Accord BioPharma's Biosimilar To NEUPOGEN® (filgrastim) 2/17/2026

    Accord BioPharma, the U.S. specialty division of Intas Pharmaceuticals, Ltd., focused on the development of oncology, immunology, and critical care therapies, announced that the U.S. Food and Drug Administration (FDA) has approved FILKRI™ (filgrastim-laha), a biosimilar to NEUPOGEN® (filgrastim), for patients with cancer receiving myelosuppressive chemotherapy; patients with acute myeloid leukemia receiving induction or consolidation chemotherapy; patients with cancer undergoing bone marrow transplantation; patients with severe chronic neutropenia; and patients acutely exposed to myelosuppressive doses of radiation (hematopoietic syndrome of acute radiation syndrome).1

  4. U.S. FDA Clears IND For Phase 1 Study Of Henlius' Subcutaneous Daratumumab Biosimilar 2/16/2026

    Shanghai Henlius Biotech, Inc. today announced that the Investigational New Drug (IND) application for HLX15-SC, the subcutaneous formulation of HLX15, the Company’s daratumumab biosimilar candidate (recombinant anti-CD38 fully human monoclonal antibody), has been cleared by the U.S. Food and Drug Administration (FDA). The study is intended for first-line treatment of multiple myeloma.

  5. STADA And Bio-Thera Receive European Marketing Authorization For Gotenfia, A Biosimilar To Simponi 2/13/2026

    Global specialty, generic and consumer healthcare medicines company STADA and Bio-Thera Solutions (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and biosimilars, have received a marketing authorization from the European Commission[1] for their Gotenfia® (golimumab) biosimilar referencing Simponi®.

  6. Samsung Bioepis Reaches Settlement Agreement For Eylea (Aflibercept) Biosimilar In The United States 2/12/2026

    Samsung Bioepis Co., Ltd. has signed a settlement and license agreement with Regeneron concerning the commercialization of OPUVIZ (aflibercept-yszy), a biosimilar to Eylea1 2 mg (aflibercept), in the United States (US), following an earlier settlement covering Europe and the Rest of the World (RoW).2

  7. AAM's John Murphy III Testifies Before Congress On Lowering Health Care Costs And The Prescription Drug Supply Chain 2/11/2026

    The Association for Accessible Medicines President and CEO John Murphy III today testified at a hearing, Lowering Health Care Costs for All Americans.

  8. Lotus Pharmaceutical Becomes Commercialization Partner For Formycon's Keytruda Biosimilar Candidate FYB206 Across Major Parts Of The Asia-Pacific Region 2/10/2026

    Formycon AG and Lotus Pharmaceutical (“Lotus”) today announced the conclusion of an exclusive license agreement for Formycon’s Keytruda (1) biosimilar candidate FYB206 (Pembrolizumab).

  9. MedImpact Offers Humira Biosimilar 95% Below The Cost Of Humira To Any Hospital Or Pharmacy 2/10/2026

    MedImpact Holdings, Inc. today announced the launch of an unbranded biosimilar to Humira® (adalimumab) priced at 95% below the brand-name cost.

  10. Celltrion's Stoboclo Listed On CVS Caremark Formulary, One Of The Three Largest PBMs In The U.S.... Successive Listings With Major PBMs Accelerate Early Market Penetration 2/6/2026

    Celltrion announced today that Stoboclo (denosumab), its biosimilar treatment for bone-related diseases, has been listed as a preferred product on the formulary of CVS Caremark, one of the three largest pharmacy benefit managers (PBMs) in the United States.