Biosimilar Development News

  1. Biosimilars Forum Applauds House Of Representatives Committee On Energy And Commerce For Including PBM Reform In Reconciliation Package 5/13/2025

    “Biosimilars Forum applauds the House of Representatives Committee on Energy and Commerce for including PBM reform in its first draft of the reconciliation package. Reforming the PBM Monopoly is critical to lowering prescription drug prices for Americans and providing more lower-cost drug options, like biosimilars.

  2. ProBioGen Enters Agreement With Polpharma Biologics To Provide High-Performance Cell Line Development Services 5/7/2025

    ProBioGen announced today an agreement with Polpharma Biologics, an international biotech company dedicated to the development and manufacture of biosimilars. Under this agreement ProBioGen will conduct high-performance cell line development services for Polpharma's biosimilar candidate, supporting their expanding pipeline.

  3. Biocon Biologics Secures Strong Market Access Coverage For Yesintek™ In The United States Covering 100+ Million Lives 5/5/2025

    Biocon Biologics Ltd. (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd (BSE code: 532523, NSE: BIOCON), today announced the Company has secured multiple market access agreements for Yesintek™ (ustekinumab-kfce), its biosimilar to Stelara® (ustekinumab).

  4. Teva And Alvotech Announce FDA Approval Of Interchangeability For SELARSDI™ (ustekinumab-aekn) With Stelara® (ustekinumab) 5/5/2025

    Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), and Alvotech (NASDAQ: ALVO) today announced that the U.S. Food and Drug Administration (FDA) has approved SELARSDI™ (ustekinumab-aekn) injection as interchangeable with the reference biologic Stelara® (ustekinumab).

  5. Henlius Enters Into License Agreement With Sandoz For Proposed Ipilimumab Biosimilar 4/29/2025

    On April 29, 2025, Shanghai Henlius Biotech, Inc. announced a licensing agreement with Sandoz, the global leader in generic and biosimilar medicines, granting exclusive commercialization rights for its self-developed ipilimumab biosimilar HLX13 in the United States, 42 European countries and regions, Japan, Canada, and Australia.

  6. Bone Health: Biocon Biologics Receives Positive CHMP Opinions For Biosimilar Denosumab In Europe 4/29/2025

    Biocon Biologics Ltd (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd (BSE code: 532523) (NSE: BIOCON), today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued positive opinions recommending the authorization of its denosumab biosimilars candidates for distinct therapeutic indications for bone health: Vevzuo® and Denosumab BBL (brand name is currently under approval).

  7. CuraTeQ Biologics Receives CHMP Positive Opinion For Dazublys – Trastuzumab Biosimilar 4/26/2025

    CuraTeQ Biologics, a wholly owned step-down subsidiary of Aurobindo Pharma Limited, has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending marketing authorisation of Dazublys (150 mg powder for concentrate for solution for infusion), its trastuzumab biosimilar, for the treatment of HER2-positive metastatic and early breast cancers.

  8. AEON Biopharma Appoints Industry Veteran Rob Bancroft As Chief Executive Officer 4/21/2025

    AEON Biopharma, Inc. (“AEON” or the “Company”) (NYSE: AEON), a clinical-stage biopharmaceutical company focused on developing a botulinum toxin complex for the treatment of multiple therapeutic indications, announced today the appointment of Rob Bancroft as President and Chief Executive Officer, effective April 29, 2025. Mr. Bancroft will also join AEON’s Board of Directors.

  9. Biosimilars Forum Applauds The Trump Administration For Drug Pricing Executive Order 4/16/2025

    Juliana M. Reed, executive director of the Biosimilars Forum, released the following statement following the Trump Administration’s Executive Order, which promotes the availability and streamlined development of biosimilars.

  10. Biosidus Announces Promising Interim Results From Phase III Study On Agalsidase Beta For Fabry Disease 4/16/2025

    Biosidus, an Argentinean pioneer company in biotechnology research, development, and the production of high-quality biosimilars, has announced encouraging interim results from the Phase III SMILE1 study.