Tag Archives: Inflectra

October, 2017

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 …

April, 2016

  • 5 April

    FDA Approves Celltrion’s Inflectra, a Biosimilar to Remicade

    The U.S. Food and Drug Administration today approved Inflectra (infliximab-dyyb) for multiple indications. Inflectra is administered by intravenous infusion. This is the second biosimilar approved by the FDA. Inflectra is biosimilar to Janssen Biotech, Inc.’s Remicade (infliximab), which was originally licensed in 1998. Inflectra is approved and can be prescribed by …

August, 2015

  • 21 August

    TGA Approves Hospira’s mAb Biosimilar

    MELBOURNE, Australia, Aug. 19, 2015 /PRNewswire/ — Hospira today announced that InflectraTM (infliximab), the first monoclonal antibody (mAb) biosimilar therapy, has been registered in Australia.  This registration paves the way for the Federal Government to reduce the cost of some of the most expensive medicines on the Pharmaceutical Benefits Scheme (PBS). …

June, 2015