Biosimilar Development News

  1. Zydus And Formycon Enter Into An Exclusive Partnership For The Licensing And Supply Of Biosimilar To Keytruda® (Pembrolizumab), In US And Canada 12/19/2025

    Zydus Lifesciences Limited (including its subsidiaries and affiliates), an innovation-led life-sciences company, with an international presence, today announced that its wholly owned subsidiary, Zydus Lifesciences Global FZE, United Arab Emirates has entered into a strategic partnership with Formycon AG for the exclusive licensing and supply of checkpoint inhibitor FYB206, a biosimilar of Keytruda®1 (Pembrolizumab) in the USA and Canada market.

  2. Golimumab Biosimilar Gotenfia From STADA And Bio-Thera Receives Positive CHMP Opinion 12/12/2025

    Global specialty, generic and consumer healthcare medicines company STADA and Bio-Thera Solutions (688177:SH), a commercial-stage biopharmaceutical company developing a pipeline of innovative therapies and biosimilars, today received a positive opinion from the European Medicines Agency (EMA), recommending approval for their Gotenfia® (golimumab) biosimilar candidate referencing Simponi®.

  3. Chime Biologics Announces Strategic Collaboration With Beijing Libang Pharmaceutical On Global Blinatumomab Biosimilar Program 12/10/2025

    Chime Biologics, a leading global CDMO that enables its partners' success in biologics, today announced strategic collaboration with Beijing Libang Pharmaceutical Co., Ltd. on the development, manufacturing, and overseas licensing and financing of a blinatumomab biosimilar

  4. Biosimilars Forum Calls For Congress To Pass The Skinny Labels, Big Savings Act To Support Safe, Effective And Lower-Cost Biosimilars 12/10/2025

    “The Biosimilars Forum supports the Skinny Labels, Big Savings Act. This bipartisan legislation will promote free-market competition of biosimilars and improve patient access to lower-cost, FDA-approved medications.

  5. Zydus Launches Biosimilar Denosumab 120 mg SC – Protecting Bone Health In Cancer Patients 12/10/2025

    Zydus Lifesciences Ltd., an innovation-led healthcare company, with an international presence has launched ‘Zyrifa’, a Denosumab biosimilar.

  6. Polpharma Biologics And Libbs Farmacêutica Sign Licensing Agreement For A Biosimilar For Autoimmune Diseases 12/10/2025

    Polpharma Biologics, a leading biopharmaceutical company specializing in the development and manufacturing of biosimilars, is thrilled to announce the signing of a landmark licensing agreement with the Brazilian company Libbs Farmacêutica! Through this strategic partnership, Libbs Farmacêutica will gain exclusive rights to commercialize a cutting-edge biosimilar for autoimmune diseases in the rapidly growing Brazilian market.

  7. Sandoz Completes Strategic Acquisition Of Just-Evotec Biologics EU SAS, Asserting Biosimilars Leadership 12/8/2025

    Sandoz, the global leader in affordable medicines, today announced the completion of the acquisition of Just-Evotec Biologics EU SAS (JEB SAS) from Evotec SE.

  8. Professor Sarfaraz K. Niazi Files Landmark Citizen Petition Urging The FDA To Modernize Biosimilar Approval Pathways And Transform Global Access To Biological Medicines 12/8/2025

    Professor Sarfaraz K. Niazi, Ph.D., a leading authority in pharmaceutical sciences and internationally recognized biosimilars expert, has filed a major Citizen Petition with the U.S. Food and Drug Administration (FDA) calling for sweeping regulatory and scientific reforms that would dramatically reduce the cost, duration, and complexity of biosimilar development—ushering in a new era of global access to life-saving biological drugs.

  9. Lupin And Valorum Enter Into An Exclusive Licensing Agreement For Biosimilar Armlupeg (Pegfilgrastim-unne) In The United States 12/4/2025

    Global pharma major Lupin Limited (Lupin) today announced that it has entered into an Exclusive Licensing Agreement with Valorum Biologics (Valorum), a biosimilar specialist in the U.S., for its biosimilar Armlupeg (pegfilgrastim-unne).

  10. Mexico Will Receive New Biosimilars For Bone Health Through Saya Biologics In Collaboration With Enzene, A CDMO partner 12/4/2025

    Saya Biologics (“Saya Bio”), a Mexican biopharmaceutical company committed to expanding access to innovative biologic treatments, today announced a strategic partnership with Enzene Biosciences Ltd. (“Enzene”), a global continuously innovative development and manufacturing organization (CDMO), to support Saya Bio’s launch into Mexico of two innovative therapies to target osteoporosis.