Biosimilar Development News

  1. FDA Advisory Committee Recommends Approval Of Pfizer’s Proposed Biosimilar To Epogen/Procrit Across All Indications
    5/25/2017

    Pfizer Inc. recently announced the United States (U.S.) Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) recommended approval of the Company’s proposed epoetin alfa biosimilar across all indications. 

  2. Biosimilars Market Is Expected To Reach USD 10.90 Billion By 2021
    5/24/2017

    Biosimilars Market by Product (Recombinant Non-glycosylated Proteins (Insulin, rHGH, Interferon), glycosylated (mAb, EPO), Peptides (Glucagon, Calcitonin)), Manufacturing (In-House, CM0) & Application (Oncology, Blood Disorders) - Global Forecast To 2021.

  3. Miraca Life Sciences Again Expands Therapeutic Drug Monitoring With Addition Of First Biosimilar Inflectra
    5/23/2017

    Miraca Life Sciences, the largest U.S. independent anatomic pathology laboratory, has further expanded its InformTx therapeutic drug monitoring (TDM) capabilities with the addition of testing for Inflectra® (infliximab-dyyb), which is the first biosimilar drug in the test offering. 

  4. Vizient, Inc. Submits Comments To The FDA About Biosimilar Interchangeability, Looks Forward To Working Toward Lowering Drug Costs
    5/22/2017

    On May 19, 2017, Vizient, Inc. submitted comments to the Food and Drug Administration (FDA) regarding its notice “Considerations on Demonstration Interchangeability with a Reference Product.” 

  5. FUJIFILM KYOWA KIRIN BIOLOGICS Announces Marketing Authorisation Application For FKB327 Accepted For Review By European Medicines Agency
    5/22/2017

    FUJIFILM KYOWA KIRIN BIOLOGICS Co., Ltd. (President & CEO: Hideaki Nomura; “Fujifilm Kyowa Kirin Biologics”) announces that on May 18, 2017, the European Medicines Agency (EMA) has accepted for review the Marketing Authorisation Application (MAA) for FKB327, an adalimumab biosimilar candidate to the fully human anti-TNF-α1 monoclonal antibody, Humira. 

  6. Adalimumab Biosimilar Market Forecast 2017: Oncobiologics, Pfizer, Samsung Bioepsis, Boehringer Ingelheim
    5/19/2017

    A market study based on the " Adalimumab Biosimilar Market " across the globe, recently added to the repository of Market Research, is titled ‘Global Adalimumab Biosimilar Market 2017’.

  7. Sanofi Receives CHMP Recommendation For Approval Of Insulin Lispro Biosimilar
    5/19/2017

    Sanofi announced recently that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for the marketing authorization of Insulin lispro Sanofi (insulin lispro 100 Units/mL).

  8. GE Healthcare’s FlexFactory To Power Dr. Reddy’s Biosimilar Expansion Plans
    5/18/2017

    GE Healthcare recently announced that Dr. Reddy’s Laboratories Limited will install India’s first-ever FlexFactory, a single-use manufacturing platform to expand the biologics production capacity at its facility in Hyderabad, India.

  9. Cinfa Biotech Announces Positive Top-Line Data From Second Clinical Study With Pegfilgrastim Biosimilar Candidate B12019
    5/18/2017

    Cinfa Biotech S.L., the biosimilars company of Cinfa Group, recently announced positive top-line data from the second clinical trial with its lead development candidate B12019, a biosimilar version of Neulasta (pegfilgrastim) to treat chemotherapy-induced neutropenia.

  10. Cinfa Biotech Announces Positive Top-line Data From Second Clinical Study Of Pegfilgrastim Biosimilar Candidate B12019
    5/17/2017

    Cinfa Biotech S.L., the biosimilars company of Cinfa Group, recently announced positive top-line data from the second clinical trial with its lead development candidate B12019, a biosimilar version of Neulasta (pegfilgrastim) to treat chemotherapy-induced neutropenia.