Biosimilar Development News

  1. Samsung Bioepis Reaches Settlement Agreement For Eylea (Aflibercept) Biosimilar In The United States 2/12/2026

    Samsung Bioepis Co., Ltd. has signed a settlement and license agreement with Regeneron concerning the commercialization of OPUVIZ (aflibercept-yszy), a biosimilar to Eylea1 2 mg (aflibercept), in the United States (US), following an earlier settlement covering Europe and the Rest of the World (RoW).2

  2. AAM's John Murphy III Testifies Before Congress On Lowering Health Care Costs And The Prescription Drug Supply Chain 2/11/2026

    The Association for Accessible Medicines President and CEO John Murphy III today testified at a hearing, Lowering Health Care Costs for All Americans.

  3. Lotus Pharmaceutical Becomes Commercialization Partner For Formycon's Keytruda Biosimilar Candidate FYB206 Across Major Parts Of The Asia-Pacific Region 2/10/2026

    Formycon AG and Lotus Pharmaceutical (“Lotus”) today announced the conclusion of an exclusive license agreement for Formycon’s Keytruda (1) biosimilar candidate FYB206 (Pembrolizumab).

  4. MedImpact Offers Humira Biosimilar 95% Below The Cost Of Humira To Any Hospital Or Pharmacy 2/10/2026

    MedImpact Holdings, Inc. today announced the launch of an unbranded biosimilar to Humira® (adalimumab) priced at 95% below the brand-name cost.

  5. Celltrion's Stoboclo Listed On CVS Caremark Formulary, One Of The Three Largest PBMs In The U.S.... Successive Listings With Major PBMs Accelerate Early Market Penetration 2/6/2026

    Celltrion announced today that Stoboclo (denosumab), its biosimilar treatment for bone-related diseases, has been listed as a preferred product on the formulary of CVS Caremark, one of the three largest pharmacy benefit managers (PBMs) in the United States.

  6. 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).

  7. 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.

  8. 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.

  9. 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.

  10. 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.