Biosimilar Development News

  1. Newly Established Samsung Epis Holdings To Drive Growth For Samsung Bioepis And A New Subsidiary 11/2/2025

    Samsung Epis Holdings Co., Ltd. today announced its establishment as a new investment holding company, following the spin-off of Samsung Bioepis Co., Ltd. from Samsung Biologics (KRX: 207940.KS).

  2. Alvotech Provides Update On The Status Of U.S. Biologics License Application For AVT05 11/2/2025

    Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today that the U.S.

  3. U.S. FDA Grants Interchangeability Designation To Celltrion's denosumab Biosimilars, STOBOCLO® (denosumab-bmwo) And OSENVELT® (denosumab-bmwo) 10/30/2025

    Celltrion, Inc. today announced that the U.S. Food and Drug Administration (FDA) has designated STOBOCLO® (denosumab-bmwo) and OSENVELT® (denosumab-bmwo) as interchangeable biosimilars to the reference products PROLIA® (denosumab) and XGEVA® (denosumab), respectively, for all approved indications.

  4. Vizient Applauds FDA's Recent Actions To Accelerate Biosimilar Development And Lower Costs 10/30/2025

    Vizient commends the U.S. Food and Drug Administration (FDA) for announcing actions to accelerate biosimilar development, including releasing new draft guidance that provides greater clarity on when comparative efficacy studies (CES) are not required for biosimilar approval which should reduce burdens currently associated with biosimilar approvals in certain circumstances.

  5. Prime Therapeutics Supports FDA's Updated Biosimilar Recommendations 10/30/2025

    Prime Therapeutics LLC (Prime) released the following statement on the U.S. Food and Drug Administration's (FDA) recent biosimilar announcement:

  6. Biosimilars Forum Applauds FDA And Commissioner Dr. Marty Makary For Supporting Safe, Effective And Lower-Cost Biosimilars 10/29/2025

    Juliana M. Reed, executive director of the Biosimilars Forum, released the following statement following today’s updated Scientific Considerations Guidance from the U.S. Food and Drug Administration (FDA).

  7. The Biosimilars Forum Thanks And Commends Trump Administration Healthcare Leaders For Supporting Lower-Cost, Safe And Effective Biosimilars 10/29/2025

    Juliana M. Reed, executive director of the Biosimilars Forum, released the following statement following the FDA’s formal issuance of new draft guidance (chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https://www.fda.gov/media/189366/download)—accompanied by a press release (https://www.fda.gov/news-events/press-announcements/fda-moves-accelerate-biosimilar-development-and-lower-drug-costs) and fact sheet (chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https://www.fda.gov/media/189382/download?attachment) —on bringing lower-cost biosimilar drugs to Americans that need them.

  8. AAM And The Biosimilars Council Applaud FDA Announcement On Biosimilars Clinical Efficacy Studies And Interchangeability 10/29/2025

    The Association for Accessible Medicines, the trade association representing America’s manufacturers of generic and biosimilar medicines, and its Biosimilars Council, today applauded the announcement by the Food and Drug Administration to streamline approval processes for biosimilar medicines.

  9. GlycoNex Announces Last Patient Dosed In Phase 3 Trial Of SPD8, A Denosumab Biosimilar For Osteoporosis 10/29/2025

    GlycoNex, Inc. (4168, hereinafter referred to as GNX), today announced that the last patient has received the final dose in its Phase 3 clinical study of SPD8, a biosimilar to denosumab for the treatment of osteoporosis.

  10. Rep. Pfluger Statement On Trump Administration's Biosimilar Announcement 10/29/2025

    Today, Congressman August Pfluger (TX-11) released the following statement in response to the Trump administration's biosimilar announcement (https://www.fda.gov/news-events/press-announcements/fda-moves-accelerate-biosimilar-development-and-lower-drug-costs).