Tag Archives: Enbrel

October, 2018

November, 2016

  • 7 November

    FDA Expands Approval of Enbrel for Use in Children with Plaque Psoriasis

    THOUSAND OAKS, Calif., Nov. 4, 2016 /PRNewswire/ — Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for the expanded use of ENBREL® (etanercept), making it the first and only systemic therapy to treat pediatric patients (ages 4-17) with chronic moderate-to-severe plaque …

July, 2016

January, 2016

  • 11 January

    Baxalta and Coherus’ Enbrel Biosimilar Meets Primary Endpoint in Late-Stage Study

    REDWOOD CITY, Calif., and BANNOCKBURN, Ill., Jan. 11, 2016 (GLOBE NEWSWIRE) — Coherus BioSciences, Inc. (NASDAQ:CHRS) and Baxalta Incorporated (NYSE:BXLT) today announced that CHS-0214, a proposed biosimilar of Enbrel® (etanercept), met its primary endpoint in a confirmatory, double-blind, randomized, controlled, two-part clinical study. This ongoing study is evaluating the efficacy and safety of CHS-0214 compared to Enbrel in patients …

November, 2015

  • 20 November

    EU Endorses Biogen and Samsung Bioepis’ Biosimilar Version of Enbrel

    ZUG, Switzerland–(BUSINESS WIRE)–Biogen (NASDAQ:BIIB) today announced further progress as part of its commitment to biosimilars. Samsung Bioepis, the joint venture between Samsung Biologics and Biogen, has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for the marketing authorization …

October, 2015

  • 5 October

    FDA Accepts Sandoz’s BLA for Biosimilar Etanercept

    Holzkirchen, October 2, 2015 – Sandoz, a Novartis company and the global leader in biosimilars, announced today that the US Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) under the 351 (k) pathway for its proposed biosimilar to Amgen’s US-licensed Enbrel®* (etanercept) – a tumor necrosis factor …

June, 2015