Biosimilar Development News

  1. US Food And Drug Administration (FDA) Approves Henlius And Organon's BILDYOS (denosumab-nxxp) And BILPREVDA (denosumab-nxxp), Biosimilars To PROLIA (denosumab) And XGEVA (denosumab), Respectively 9/2/2025

    Shanghai Henlius Biotech, Inc. (2696.HK), and Organon today announced the US Food and Drug Administration (FDA) has approved BILDYOS (denosumab-nxxp) injection 60 mg/mL and BILPREVDA (denosumab-nxxp) injection 120 mg/1.7 mL, biosimilars to PROLIA (denosumab) and XGEVA (denosumab), respectively, for all indications of the reference products.1,2

  2. Professor Sarfaraz K. Niazi Secures First-Ever FDA Acceptance To Waive Clinical Efficacy Studies For Monoclonal Antibody Biosimilars 9/1/2025

    In a groundbreaking milestone for global healthcare and pharmaceutical innovation, Professor Sarfaraz K. Niazi, Adjunct Professor at the University of Illinois at Chicago and founder of multiple biopharmaceutical enterprises, has secured the first-ever FDA acceptance to waive clinical efficacy studies (CESs) for monoclonal antibody biosimilars.

  3. Prometheus Laboratories Announces Collaboration With Celltrion For Anser Testing 8/27/2025

    Prometheus Laboratories Inc. ("Prometheus"), a leader in precision healthcare, today announced a collaboration with Celltrion USA, Inc. ("Celltrion USA") to validate and expand the upper limit of quantitation for Anser IFX (infliximab) therapeutic drug monitoring (TDM) testing for patients receiving ZYMFENTRA (infliximab-dyyb).

  4. Abbott Receives Regulatory Approval For The First Denosumab Biosimilar In Thailand, Expanding Access To Bone Disease Treatment 8/26/2025

    Abbott (NYSE: ABT), the global healthcare leader, has received regulatory approval for the first denosumab biosimilar in Thailand, expanding access to advanced therapies for osteoporosis and cancer-related bone loss.

  5. AcariaHealth Sparks Innovation At 2025 Healthcare Advocate Summit With Hackathon And Expert Panels 8/26/2025

    AcariaHealth, a leader in specialty pharmacy solutions and a Centene Corporation company (NYSE: CNC), is taking center stage at the 2025 Healthcare Advocate Summit (Sept. 2–5) in Las Vegas with a first-of-its-kind "Reimagine Access" Hackathon and two can't-miss expert sessions.

  6. The European Commission (EC) Approves Bio-Thera Solutions' BAT2206 (USYMRO®, ustekinumab), A Biosimilar Referencing Stelara® 8/26/2025

    Bio-Thera Solutions Inc. (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and biosimilars, today announced that the EC has approved BAT2206 (ustekinumab), a biosimilar referencing Stelara® following a positive opinion from the EMA's CHMP on June 19, 2025.

  7. Bio-Thera And STADA Extend Biosimilars Alliance To Tocilizumab 8/22/2025

    Bio-Thera Solutions (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and biosimilars, and global specialty, generic and consumer healthcare medicines company STADA Arzneimittel AG have agreed to extend their biosimilars alliance to cover tocilizumab, an immunosuppressant monoclonal antibody indicated for certain inflammatory conditions.

  8. Advanz Pharma And Alvotech Receive European Approval For Mynzepli®, Biosimilar To Eylea® 8/21/2025

    Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide and Advanz Pharma Holdco Limited (“Advanz Pharma”), a UK headquartered global pharmaceutical company with a strategic focus on specialty, hospital, and rare disease medicines in Europe, today announced that the European Commission has approved Mynzepli® as a biosimilar to Eylea® (aflibercept), in a pre-filled syringe and vial.

  9. BioDlink's Bevacizumab Approved For Market Launch In Indonesia, Marking Fourth Consecutive Emerging Market Authorization 8/21/2025

    BioDlink announced that its Bevacizumab Injection has obtained marketing authorization from Indonesia's National Agency of Drug and Food Control (BPOM). This marks BioDlink's fourth international approval within two months – following Nigeria, Pakistan, and Colombia – signaling accelerated BioDlink's global expansion into a sustained commercialization phase.

  10. Accord BioPharma Announces Commercial Launch Of IMULDOSA® (ustekinumab-srlf) Prefilled Syringes At Lowest WAC Price Among Branded Biosimilars To STELARA® (ustekinumab) 8/18/2025

    Accord BioPharma, Inc., the specialty division of Intas Pharmaceuticals, Ltd., focused on the development of oncology, immunology, and critical care therapies, announced today the commercial launch of IMULDOSA® (ustekinumab-srlf), a biosimilar to STELARA® (ustekinumab). IMULDOSA prefilled syringes, which would represent the majority of the presentations in the ustekinumab market, are priced at the lowest wholesaler acquisition cost (WAC) among all branded ustekinumab biosimilars at a 92% discount from STELARA. FDA-approved for the same indications as the reference product, IMULDOSA represents Accord BioPharma's third in-market biosimilar and furthers the company's mission to expand patient access to potentially life-changing biologic therapies.¹ Accord BioPharma is committed to providing patients with greater access to ustekinumab through this significant cost reduction.