Biosimilar Development News

  1. Alvotech Announces Positive Top-Line Results From Pivotal Pharmacokinetic Study For Proposed Biosimilar To Entyvio® 2/5/2026

    Alvotech (NASDAQ: ALVO), a global biotechnology company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today positive top-line results from a pharmacokinetic (PK) study for AVT80, a biosimilar candidate to Entyvio® (vedolizumab).

  2. CVS Health Helps Customers Accelerate Biosimilar Adoption Through Formulary Changes - Supporting Affordable Options For Osteoporosis Care 2/5/2026

    CVS Health® (NYSE: CVS) today announced new steps to further help customers expand adoption of lower-cost biosimilar medications.

  3. Saya Biologics And Kashiv BioSciences Partner To Bring A Biosimilar Supportive Oncology Therapy To Mexico And CAC 2/4/2026

    Saya Biologics (Saya Bio), a Mexican biopharmaceutical company committed to expanding access to high-quality and affordable biologic treatments, and Kashiv BioSciences, a vertically integrated global biopharmaceutical company specializing in the research, development, and manufacturing of biologic medicines, have announced a strategic collaboration to register and commercialize a supportive oncology therapy in Mexico and the Central America & Caribbean (CAC) region.

  4. AGC Biologics Seattle Site Now Certified To Manufacture Biologics For Largest Pharmaceutical Market In South America 2/3/2026

    The Seattle facility of AGC Biologics, your friendly CDMO expert, has received a Good Manufacturing Practices Certification from Agência Nacional de Vigilância Sanitária (Anvisa), Brazil’s health regulatory authority.

  5. Sandoz Canada Launches First Ophthalmology Biosimilar 2/2/2026

    Sandoz, the global leader in affordable medicines, today announced the launch of Enzeevu® (aflibercept) in Canada, its first ophthalmology biosimilar, expanding access to affordable treatment options for people living with serious retinal diseases across Canada.

  6. Alvotech Enters Supply And Commercialization Agreements For Canada And Australia & New Zealand Covering Multiple Biosimilar Candidates 2/2/2026

    Alvotech (NASDAQ: ALVO), a global biotechnology company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that it has entered into supply and commercialization agreements with Sandoz covering multiple biosimilar candidates in Canada, and in Australia and New Zealand.

  7. Samsung Bioepis Reaches Settlement Agreement For Eylea (Aflibercept) Biosimilar In Europe And The Rest Of The World 1/30/2026

    Samsung Bioepis Co., Ltd. has signed a settlement and license agreement with Regeneron and Bayer concerning the commercialization of SB151, a biosimilar to Eylea2 2 mg (aflibercept 40 mg/mL solution), in countries excluding the United States and Canada.

  8. Patent Settlement Secures Pathway For ADVANZ PHARMA And Alvotech To Market Eylea Biosimilar 1/30/2026

    ADVANZ PHARMA Holdco Limited (“ADVANZ PHARMA” or “the Company”), a UK headquartered global pharmaceutical company with a strategic focus on speciality, hospital, and rare disease medicines, today announced that its partner Alvotech has reached a licensing and settlement agreement with Regeneron and Bayer, resolving all remaining patent disputes worldwide related to Alvotech’s biosimilar to Eylea 2mg (aflibercept 40 mg/mL solution), which is approved for marketing in the European Economic Area and the United Kingdom.

  9. Alvotech Secures Settlement Agreement in Global Markets For Its Biosimilar To Eylea® 2mg 1/29/2026

     Alvotech (NASDAQ: ALVO), a global biotechnology company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that it has reached a licensing and settlement agreement with Regeneron and Bayer, resolving all remaining patent disputes worldwide related to Alvotech’s biosimilar to Eylea® 2mg (aflibercept 40 mg/mL solution), which is approved for marketing in the European Economic Area, United Kingdom and Japan.

  10. MS Pharma Group Signs Exclusive Biosimilars Partnership Agreement With Hetero 1/26/2026

    MS Pharma Group, a leading regional pharmaceutical company in the MENA region, has signed a strategic partnership agreement with Hetero Group, a global pharmaceutical company, to localize five established biosimilars across key therapeutic areas, including oncology, immunology and hematology.