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. Celltrion Receives Positive CHMP Opinion For SteQeyma (ustekinumab Biosimilar) Autoinjector 12/17/2025

    Celltrion, Inc. today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion of autoinjector of SteQeyma, a biosimilar to Stelara (ustekinumab), for the treatment of plaque psoriasis, psoriatic arthritis (PsA) and Crohn’s disease (CD).

  3. Lupin Receives Positive CHMP Opinion For Biosimilar Ranibizumab 12/17/2025

    Global pharma major Lupin Limited (Lupin) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending marketing authorization for its biosimilar ranibizumab, RanluspecTM, for both vial and pre-filled syringe presentations.

  4. Biocon Biologics Signs Settlement And License Agreement To Commercialize Biosimilar Aflibercept Worldwide 12/13/2025

    Biocon Biologics Ltd (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd, announced today a new settlement and license agreement with Regeneron and Bayer for biosimilar Aflibercept (40mg/ml) in Europe and the rest of the world, which follows an earlier settlement covering the United States and Canada.

  5. 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®.

  6. 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

  7. 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.

  8. 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.

  9. 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.

  10. 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.