Biosimilar Development News

  1. 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).

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. MedImpact Offers Low Cost, Unbranded Ustekinumab-aekn Biosimilar To Any Specialty Pharmacy In The US 8/18/2025

    MedImpact Holdings Inc. today announced that it will have access to an unbranded biosimilar ustekinumab-aekn at a significantly lower cost than the reference Stelara (ustekinumab).

  10. BioDlink Accelerates Global Expansion With Bevacizumab Launch In Colombia And Pakistan 8/13/2025

    BioDlink announced that its self-developed bevacizumab injection biosimilar has received marketing approval from Colombia's National Institute for Surveillance of Medicines and Foods (INVIMA) and Pakistan's Drug Regulatory Authority of Pakistan (DRAP).