Biosimilar Development News

  1. Robust Biosimilars Market Could Save U.S. Taxpayers $7B Annually, New Analysis Finds 5/28/2020

    U.S. taxpayers and the health care system at-large could save up to $7B annually with a stronger, more competitive biosimilars market, a substantial increase from the current annual cost-savings of $240.4M, according to a new analysis.

  2. FDA Accepts For Review Fresenius Kabi’s BLA Submission For Pegfilgrastim Biosimilar 5/27/2020

    Fresenius Kabi, a global health care company that specializes in medicines and technologies for infusion, transfusion and clinical nutrition, announced today the U.S. Food and Drug Administration has accepted for review the company’s Biologics License Application (BLA) for MSB11455, the company’s pegfilgrastim biosimilar candidate for Neulasta

  3. Henlius Received IND Approval For Denosumab Biosimilar HLX14 From NMPA 5/27/2020

    Shanghai Henlius Biotech, Inc. (2696.HK) announced that an investigational new drug (IND) application has been approved by the National Medical Products Administration (NMPA) of HLX14, a recombinant anti-RANKL fully human monoclonal antibody injection, for the treatment of postmenopausal women with osteoporosis at high risk for fracture. HLX14 is a Denosumab biosimilar independently developed by Henlius.

  4. Fresenius Kabi’s Regulatory Submission For Pegfilgrastim Biosimilar Accepted For Review By EMA 5/22/2020

    Fresenius Kabi, a global healthcare company that specializes in lifesaving medicines and technologies, announced today that the European Medicines Agency (EMA) has accepted for review the company’s Marketing Authorization Application (MAA) for MSB11455, a biosimilar candidate of Neulasta (pegfilgrastim).

  5. AMA: U.S. Health Insurance Plans Prefer Brand Biologics Twice As Often As Lower-Cost Biosimilars 5/21/2020

    A new analysis of 17 of the largest commercial health plans published in the Journal of the American Medical Association found that higher-cost, reference biologics are preferred twice as often as lower-cost biosimilars. The study found that only 14% of the U.S. health plans covered biosimilars as preferred, revealing biosimilar coverage differences across health plans that lead to inadequate patient access to lower-cost therapies.

  6. Biocon Biologics Receives EU GMP Certification For Multiple Biosimilars Manufacturing Facilities In Bengaluru; Expands Its Manufacturing Capacity 5/19/2020

    Biocon Ltd, Asia’s premier biopharmaceuticals company, announced today that its subsidiary Biocon Biologics India Ltd. has received the Certificate of GMP compliance from EMA for multiple Biologics Drug Substance (DS) and Drug Product (DP) manufacturing facilities at Biocon Park, Bengaluru.

  7. First Subjects Dosed In Australian Phase I Clinical Study Of A Denosumab Biosimilar 5/18/2020

    JHL Biotech, Inc. today announced that the first group of subjects has been randomized and dosed last week in the company's Australian Phase I Clinical Trial of JHL1266 in healthy subjects.

  8. Samsung Bioepis Announces 24-Week Interim Results From A Phase 3 Trial Of SB11, Proposed Ranibizumab Biosimilar 5/18/2020

    Samsung Bioepis Co., Ltd. announced today that the primary endpoints have been met in the randomized, double-masked, phase 3 trial comparing the efficacy, safety and immunogenicity of SB11, a ranibizumab biosimilar candidate, to reference ranibizumab in patients with neovascular age-related macular degeneration (nAMD).

  9. Samsung Bioepis Announces Four-Year Follow-Up Data For Biosimilar ONTRUZANT (trastuzumab-dttb) In Early Or Locally Advanced HER2-Positive Breast Cancer 5/15/2020

    Samsung Bioepis Co., Ltd. announced today that four-year follow-up results of the Phase 3 study for ONTRUZANT, a biosimilar of the reference medicine HERCEPTIN1 (trastuzumab), will be presented at the ASCO20 Virtual Scientific Program organized by the American Society of Clinical Oncology (ASCO), which will be held from May 29-31, 2020.

  10. Formycon Announces Update On Biosimilar Programs 5/15/2020

    In consideration of the current developments of the corona pandemic, Formycon AG today announces news on its development portfolio.