Tag Archives: Biosimilars 20/20

November, 2015

September, 2015

  • 9 September

    Biosimilars’ Success in the US: Will Physicians Rule the Road?

    By Kathleen P. Wolff, MBA Specialty Pharma Journal As the high cost of new biologic medicines sends U.S. healthcare costs soaring, payers are anxiously anticipating the introduction of biosimilar medicines – biological products, approved by FDA because they are highly similar to an already FDA-approved biological product. However, there is one …

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

May, 2015

  • 13 May

    FDA Unveils New Guidance Document for Biosimilars

    On Tuesday, the US Food and Drug Administration (FDA) released a revised document providing additional insight into how the agency plans to regulate biosimilars. The newly-released guidance document that answers common questions from companies interested in developing biosimilars, biologics license application (BLA) holders and other interested parties. The document, Biosimilars: …

  • 11 May

    Two Biocon Biosimilars Enter Late-Stage Studies

    Asia’s Biocon recently announced an update on clinical progress of its programs, saying that two of its biosimilar candidates have entered late-stage studies. The company has partnered with Britain’s Mylan on these two molecules. The companies’ pegfilgrastim (PEG-G-CSF) and Adalimumab have entered global Phase III clinical trials, which will assess …

  • 8 May

    Court Temporarily Blocks Sale of Sandoz’s Neupogen Biosimilar

    Amgen has temporarily blocked Sandoz’s Zarxio, the biosimilar version of Amgen’s Neupogen. The US Court of Appeals for the Federal Circuit in Washington has granted Amgen’s request for an injunction to stop the company from selling the drug in the US until the Court resolves the appeal. Additionally, the order …

  • 7 May

    First Nonprofit Organization Formed Dedicated to Biosimilars

    A group of leading companies involved in the development of biopharmaceuticals and biosimilars have formed the first nonprofit organization dedicated to expanding patient access to biosimilars in the US. A coalition of eleven leading companies involved in developing and manufacturing biopharmaceuticals and biosimilar drugs announced the formation of the Biosimilars …

April, 2015