The BPCIA created an abbreviated pathway for FDA approval of biological medicinal products that are “biosimilar” to an already FDA-approved product.  The FDA recently approved the first U.S. biosimilar – Sandoz’s biosimilar of Amgen’s Neupogen – and is currently reviewing at least four other proposed biosimilars.  Many innovators and biosimilars manufacturers are responding to the changing landscape for biologics by developing “biobetters”:  new and improved versions of biologic medicinal products.  While biobetters require discovery and an original Biologics License Application (BLA) with a full complement of pre-clinical and clinical data for marketing approval, they also offer many advantages.  By offering superior and longer-acting medicine, biobetters provide a competitive advantage over biosimilar products.  In addition, unlike biosimilars, they generally would be entitled to patent protection and 12 years of non-patent exclusivity under the BPCIA.

To continue reading Irena Royzman’s and Andrew D. Cohen’s article on biobetters published in Bloomberg BNA’s Life Sciences Law & Industry Report, please click here.