Biosimilar Development News

  1. European Medicines Agency Recommends Marketing Approval Of Gobivaz®, Alvotech's Proposed Biosimilar To Simponi® (golimumab) With Advanz Pharma As Commercialization Partner 9/22/2025

    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 Medicines Agency’s (EMA) Committee for Medicinal Products for Human use (CHMP) has adopted a positive opinion recommending approval for Gobivaz®, Alvotech’s proposed biosimilar to Simponi® (golimumab), a biologic used to treat several chronic inflammatory diseases.

  2. European Medicines Agency Recommends Marketing Authorization Of AVT03, Alvotech's Proposed Biosimilar To Prolia® And Xgeva® 9/22/2025

    Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human use (CHMP) has adopted a positive opinion recommending approval for AVT03, Alvotech’s proposed biosimilar to Prolia® (denosumab 60 mg/mL single use pre-filed syringe) and Xgeva® (denosumab 70 mg/mL single use vial).

  3. Alkem Launches Pertuza, A pertuzumab Biosimilar, In India For Treatment Of HER2-positive Breast Cancer 9/22/2025

    Alkem Laboratories Ltd today announced the launch of Pertuza injection 420mg/14mL, a pertuzumab biosimilar, in India for the treatment of HER2-positive breast cancer.

  4. STADA Further Builds Its Bone-Health And Oncology Offering With Positive CHMP Opinion On denosumab Biosimilars 9/19/2025

    STADA today received positive opinions from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommending that marketing authorizations be granted in Europe for its Kefdensis and Zvogra biosimilar denosumab candidates.

  5. European Commission (EC) Approves Henlius And Organon's BILDYOS (denosumab) And BILPREVDA (denosumab), Biosimilars To PROLIA (denosumab) And XGEVA (denosumab), Respectively 9/19/2025

    Shanghai Henlius Biotech, Inc. (2696.HK), and Organon today announced the European Commission (EC) has granted marketing authorization for BILDYOS (denosumab) injection 60 mg/mL and BILPREVDA (denosumab) injection 120 mg/1.7 mL, biosimilars to PROLIA (denosumab) and XGEVA (denosumab), respectively, for all indications of the reference products.1,2

  6. Alvotech Announces Marketing Approval In Japan Of Three New Biosimilars 9/19/2025

    Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that its commercialization partner in Japan, Fuji Pharma Co., Ltd. (“Fuji Pharma”), has received marketing approval for three new biosimilars from the Japanese Ministry of Health, Labor and Welfare.

  7. Rep. Pfluger Introduces Bill To Lower Prescription Drug Prices For Texans 9/19/2025

    Today, Representatives August Pfluger (TX-11) and Greg Landsman (OH-01) introduced legislation to lower prescription drug prices for Texans and ensure everyone has affordable access to the medication they need.

  8. Health Canada Approves Celltrion's Stoboclo And Osenvelt (CT-P41), denosumab Biosimilars For The Treatment Of All Indications Approved For The Reference Products, Prolia And Xgeva, Respectively 9/18/2025

    Celltrion today announced that Health Canada has approved Stoboclo and Osenvelt (CT-P41), biosimilars referencing Prolia and Xgeva, respectively for all indications of reference products.1,2

  9. Celltrion Announces Commercial Availability Of Omlyclo Across Europe At EADV 2025 9/18/2025

    Celltrion, Inc. today showcased its longstanding commitment to expanding its biosimilar portfolio in the field of immuno-dermatology by attending the 2025 European Academy of Dermatology and Venereology (EADV) Congress, held 17-20 September in Paris, France.

  10. Biocon Biologics' Yesafili (aflibercept) Now Publicly Funded In Ontario, Canada For The Advanced Treatment Of Patients With Retinal Diseases 9/18/2025

    Biocon Biologics Ltd. (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd., is pleased to announce that Yesafili (aflibercept), a biosimilar to Eylea (aflibercept) injection, in vial and prefilled syringe presentations, 2 mg/0.05 mL is now publicly funded on the Ontario Drug Benefit Formulary/Comparative Drug Index for the advanced treatment of patients with retinal diseases in Canada.