Tag Archives: ankylosing spondylitis

October, 2018

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October, 2016

  • 19 October

    Pfizer Announces the US Availability of Biosimilar Inflectra

    NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE:PFE) announced today that the company will begin shipment of INFLECTRA® (infliximab-dyyb) for injection, a biosimilar of REMICADE®1 (infliximab) to wholesalers in the United States (U.S.) in late November 2016. INFLECTRA will be the first biosimilar monoclonal antibody (mAb) and only the second biosimilar to be …

September, 2016

  • 26 September

    FDA Approves Amgen’s Humira Biosimilar for Treatment of Seven Inflammatory Diseases

    THOUSAND OAKS, Calif., Sept. 23, 2016 /PRNewswire/ — Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved AMJEVITA™ (adalimumab-atto) across all eligible indications of the reference product, Humira® (adalimumab). AMJEVITA is the first adalimumab biosimilar approved by the FDA and has been approved for the treatment …

  • 19 September

    Pfizer’s Remicade Biosimilar Candidate Succeeds in Late-Stage Study

    NEW YORK–(BUSINESS WIRE)–Pfizer Inc. (NYSE:PFE) announced the confirmatory study (REFLECTIONS B537-02) evaluating the efficacy, safety, and immunogenicity of PF-06438179 (infliximab-Pfizer) compared to Remicade® (infliximab) met its primary endpoint. The trial demonstrated equivalent efficacy of the proposed biosimilar PF-06438179 to the originator product as measured by the American College of Rheumatology …

August, 2016

  • 31 August

    FDA Approves Sandoz’s Erelzi, a Biosimilar to Enbrel

    Holzkirchen, August 30, 2016 – Sandoz, a Novartis division and the global leader in biosimilars, announced today that the US Food and Drug Administration (FDA) approved Erelzi (etanercept-szzs) for all indications included in the reference product label, including rheumatoid arthritis (RA), plaque psoriasis (PsO), psoriatic arthritis (PsA), ankylosing spondylitis (AS) …

February, 2016

  • 10 February

    FDA Panel Backs Pfizer and Celltrion’s Proposed Biosimilar Infliximab

    Pfizer Inc. commends today’s recommendation by the United States (U.S.) Food and Drug Administration’s (FDA) Arthritis Advisory Committee to approve the investigational biosimilar infliximab (CT-P13) across all eligible indications by a vote of 21 to three. Celltrion’s proposed biosimilar infliximab, to which Pfizer holds exclusive U.S. commercialization rights, is the …

April, 2015