Biosimilar Development News

  1. 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).

  2. 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director of the Biosimilars Forum, released the following statement following the FDA’s formal issuance of new draft guidance (chrome-extension://efaidnbmnnnibpcajpcglclefindmkaj/https://www.fda.gov/media/189366/download)—accompanied by a press release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.

  3. 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.

  4. 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.

  5. 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).

  6. FDA Grants Interchangeable Designation To Fresenius Kabi's Biosimilars Conexxence And Bomyntra (denosumab-bnht) 10/29/2025

    Fresenius Kabi, part of the global healthcare company Fresenius, and a leading provider of essential medicines and medical technologies, announced today that the U.S. Food and Drug Administration (FDA) designated Conexxence(1) and Bomyntra(2) (denosumab-bnht) as interchangeable biosimilars to the reference products, Prolia(3) (denosumab) and Xgeva(4) (denosumab), respectively.

  7. FDA Moves To Accelerate Biosimilar Development And Lower Drug Costs 10/29/2025

    The U.S. Food and Drug Administration (FDA) today announced significant action to make it faster and less costly to develop biosimilar medicines, which are lower-cost “generic” alternatives to biologic drugs that treat serious and chronic diseases.

  8. FDA Issues Formal Guideline Waiving Clinical Efficacy Studies For Biosimilars, Confirming Professor Niazi's 15-Year Campaign To Cut Biologic Drug Costs 10/29/2025

    In a historic move reshaping global drug development, the U.S. Food and Drug Administration (FDA) today issued a formal guideline eliminating the requirement for clinical efficacy studies (CES) in biosimilar approvals, a change long championed by Professor Sarfaraz K. Niazi, Ph.D., Adjunct Professor at the University of Illinois.

  9. Samsung Bioepis To Commercialize BYOOVIZ (ranibizumab) In Europe From January 2026 10/29/2025

    Samsung Bioepis Co., Ltd. announced today that the company has entered into an Asset Purchase Agreement (APA) with Biogen regarding Samsung Bioepis’ two ophthalmology assets: BYOOVIZ (ranibizumab), a biosimilar referencing Lucentisi (ranibizumab) and OPUVIZ (aflibercept), a biosimilar referencing Eyleaii (aflibercept) — in Europe.

  10. Evernorth Announces New Era Of Pharmacy Benefit Services To Lower Americans' Medication Costs 10/27/2025

    Evernorth, the health services division of The Cigna Group (NYSE:CI) today announced a new rebate-free pharmacy benefit model designed to help Americans stay healthy and get the medications they need by lowering costs, improving transparency, and supporting local pharmacies so care is always within reach.