Biosimilar Development News

  1. Sandoz Enters Into Commercialization And Supply Agreement For Insulin Biosimilars, Anticipating Growing Demand As Diabetes Burden Rises

    Sandoz, a Novartis division and the pioneer and global leader in biosimilars, today announced that it has entered into an agreement to commercialize biosimilar versions of insulins used in patients with type 1 and type 2 diabetes. These medicines are currently in early and clinical stages of development for the European Union (EU), United States (US) and other key territories.

  2. Community Oncology Alliance Elects New Officers And Board Members

    The Community Oncology Alliance (COA) announced recently that long-time board member and volunteer Michael Diaz, MD, a practicing medical oncologist at Florida Cancer Specialists & Research Institute (FCS), has been elected president of COA. He will take office for a one-year term beginning on January 1, 2019.

  3. Amgen Submits Biologics License Application for ABP 710 (Biosimilar Infliximab) To US Food And Drug Administration

    Amgen (NASDAQ:AMGN) today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for ABP 710, a biosimilar candidate to REMICADE® (infliximab).

  4. NeuClone Announces Its Sixth Biosimilar Candidate Perjeta (Pertuzumab) For Use In Combination Therapy With Herceptin (Trastuzumab)

    NeuClone Pharmaceuticals Ltd. (NeuClone), a clinical-stage biopharmaceutical company exclusively focused on developing high-quality biosimilar products, recently disclosed the sixth biosimilar being developed in its pipeline of monoclonal antibody (mAb) products.

  5. Pfizer Receives Positive CHMP Opinion For Oncology Biosimilar, ZIRABEV (Bevacizumab)

    Pfizer Inc. recently 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 ZIRABEV b(evaciazumb), a potential biosimilar to Avastin (bevacizumab).1

  6. Prestige BioPharma Partners With Cipla Ltd To Market Key Cancer Biosimilar

    Prestige BioPharma (“Prestige”) announced recently that it has reached a licensing agreement with Cipla Limited (“Cipla”) for its trastuzumab biosimilar (HD201) under which Cipla will have exclusive rights to distribute and market the drug in selected emerging markets.

  7. Innovent Announces Two Clinical Studies With The Anti-VEGF Monoclonal Antibody IBI305, A Biosimilar Candidate To Avastin (Bevacizumab), Met Primary Endpoints

    Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class China-based biopharmaceutical company that develops and commercializes high quality drugs, announced today that IBI305, a recombinant humanized anti-VEGF monoclonal antibody being developed as a potential biosimilar to Avastin (Bevacizumab), has met pre-defined primary endpoints in two randomized, head to head, clinical trials comparing IBI305 versus branded bevacizumab: a phase III clinical trial (CIBI305A301) in patients with advanced non-squamous non-small cell lung cancer (NSCLC) and a pharmacokinetic study (CIBI305A201) in healthy subjects.

  8. Statement From FDA Commissioner Scott Gottlieb, M.D., On New Actions Advancing The Agency's Biosimilars Policy Framework

    Our public health obligations touch on many aspects of how medical products are developed and used by patients and providers.

  9. Pfenex Submits New Drug Application To U.S. FDA Seeking Approval Of PF708 For The Treatment Of Osteoporosis

    Pfenex Inc. recently announced the submission of its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval of PF708 for the treatment of osteoporosis.

  10. Sandoz Biosimilar Zarxio (Filgrastim-Sndz) Reduced Out-Of-Pocket Costs For Medicare Patients With Breast Cancer Versus The Reference Medicine

    Sandoz, a Novartis division and the pioneer and global leader in biosimilars, presented findings from a real-world simulation model showing US Medicare cancer patients treated with biosimilar Zarxio (filgrastim-sndz) incurred less out-of-pocket (OOP) costs compared to those on reference filgrastim†. When researchers extrapolated the data to simulate one million claims (100,000 Medicare patients), Zarxio-related cost savings were projected to be approximately $9.6M.