Biosimilar Development News

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. Brazil Achieves A Historic Milestone: Blau Farmacêutica Fully Develops One Of The World's Most Advanced Biosimilars Immunotherapies 1/23/2026

     Blau Farmacêutica, a Brazilian pharmaceutical company listed on Brazilian Stock Market (B3) and a regional leader in hospital pharmaceuticals with a strong presence across Latin America, announces an important achievement for science, healthcare, and the bio-pharmaceutical industry in Brazil: the fully integrated development in Brazil of a pembrolizumab biosimilar, one of the most widely used and advanced immunotherapies for the treatment of multiple types of cancer.

  8. Over Three Dozen Groups Join The Biosimilars Council And AAM To Reiterate Support For Interchangeability Legislation 1/22/2026

    The Biosimilars Council and the Association for Accessible Medicines sent a follow up letter to U.S. Senate and House health committee leaders in support of the Biosimilar Red Tape Elimination Act. The letter was signed by over three dozen leading advocacy groups representing health care, patients, consumers, employers, taxpayers, and policy think tanks.

  9. Marketing Approval For New Specification Of Ustekinumab Biosimilar ― USTEKINUMAB BS 90 mg Syringe For S.C. Injection 「F」 1/20/2026

    Fuji Pharma Co., Ltd. ("Fuji") has announced that it has received marketing approval for a new specification of USTEKINUMAB biosimilar.

  10. Professor Sarfaraz Niazi's Scientific Framework Adopted As FDA Modernizes Clinical Trial Evaluation Through Bayesian Methods 1/20/2026

    The U.S. Food and Drug Administration (FDA) has issued new draft guidance modernizing statistical methodologies used in clinical trials, formally recognizing Bayesian approaches that align with the long-standing scientific framework developed and advanced by Professor Sarfaraz K. Niazi, PhD, for evaluating drug and biosimilar efficacy without redundant clinical studies.