Biosimilar Development News

  1. Sandoz Creates New Global Biosimilar Development, Manufacturing And Supply Unit, Appoints Industry Veteran Armin Metzger To Lead Next Phase Of Growth 3/10/2026

    Sandoz, the global leader in affordable medicines, today announces the creation of a new biosimilar development, manufacturing and supply unit.

  2. The Biosimilars Forum Commends Commissioner Makary And The FDA For Streamlining Development Of Lower-Cost Biosimilars 3/10/2026

    Juliana M. Reed, executive director of the Biosimilars Forum, released the following statement after the U.S. Food and Drug Administration (FDA) announced updated guidance to streamline biosimilar development: “New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 4). 

  3. FDA Takes Further Steps To Streamline Biosimilar Development And Make Medicines More Affordable 3/9/2026

    The U.S. Food and Drug Administration today announced another major step in its initiative to streamline the development of biosimilar medicines, which are like “generic” versions of biologic drugs.

  4. AEON Biopharma Abstract Accepted For Presentation At 2026 American Academy Of Neurology (AAN) Annual Meeting 3/5/2026

    AEON Biopharma, Inc. (“AEON” or the “Company”) (NYSE American: AEON), a biopharmaceutical company advancing ABP-450 (prabotulinumtoxinA) as a biosimilar to BOTOX® (onabotulinumtoxinA) to achieve accelerated and full-label U.S. market entry, today announced a poster presentation at the 2026 American Academy of Neurology (AAN) Annual Meeting, taking place April 18-22, 2026, in Chicago, IL.

  5. Provision Of Rs 13000 cr For BioPharma SHAKTI & 3 Dedicated Chemical Parks Is A Strategic Bet On India's Future 3/3/2026

    Budgetary Provision of ₹13,000 cr for Bio-Pharma SHAKTI and 3 dedicated Chemical Parks in the country is a strategic bet on India’s future said Union Minister of Chemicals and Fertilisers Shri J P Nadda.

  6. Formycon Announces Positive Clinical Data For Keytruda Biosimilar Candidate FYB206 (pembrolizumab) 2/25/2026

    Formycon AG announces that the primary endpoint of the pivotal Dahlia pharmacokinetics study (PK study) has been met.

  7. SteinCares And Shilpa Biologicals Strike Into Licensing Agreement To Expand Access To Biosimilars Across Latin America 2/25/2026

    SteinCares, a leading specialty healthcare company in Latin America, and Shilpa Biologicals Pvt. Ltd. (SBPL), a fully integrated biopharmaceutical subsidiary of Shilpa Medicare Limited (BSE: 530549) (NSE: SHILPAMED), announce a strategic licensing agreement to commercialize a biosimilar across Latin America.

  8. Sandoz Confirms European Commission Approval For Ranluspec (ranibizumab), Further Strengthening Overall Biosimilars Leadership And Position In Ophthalmology 2/23/2026

    Sandoz, the global leader in affordable medicines, today confirmed that the European Commission has granted marketing authorization for Ranluspec1. 

  9. Lupin Receives European Commission Approval For Biosimilar Ranibizumab 2/23/2026

    Global pharma major Lupin Limited (Lupin) today announced that it has received the approval from European Commission for its biosimilar ranibizumab, Ranluspec (for vials and pre-filled syringes), following the recent positive opinion from the Committee for Medicinal Products for Human Use.

  10. Dr. Reddy's Announces USFDA Acceptance To Review Its Biologics License Application (BLA) For Proposed Interchangeable Biosimilar, Abatacept 2/20/2026

    Dr. Reddy’s Laboratories Ltd., today announced that the US Food and Drug Administration (USFDA) has accepted for review, its 351 (k) Biologics License Application (BLA) IV for infusion formulation for DRL_AB, a proposed interchangeable biosimilar to ORENCIA (abatacept) that was submitted in December 2025.