FDA Accepts Apotex's Neupogen Biosimilar Application: Raises Issues of How the Agency Will Address Exclusivity, Previous Warning Letters to Apotex

Apotex Inc. has announced that as of February 13, 2015, the FDA has accepted for filing the company's application for filgrastim, a biosimilar version of Amgen's Neupogen. The product was jointly developed with Intas Pharmaceuticals Ltd. Filgrastim is used to help cancer patients taking chemotherapy to fight infections and fever by boosting white blood cell count. This is the fifth application submitted through the 351(k) abbreviated approval pathway created by the Biosimilar Price Competition and Innovation Act (BPCIA), and the second biosimilar submitted by Apotex. This latest Neupogen biosimilar application is noteworthy for several reasons.  Sandoz’s Neupogen Biosimilar Application Has Already Been Accepted and Recommended by FDA Advisory Committee Apotex is a few months late with its Neupogen application on the 510(k) pathway. The FDA accepted Sandoz’ biosimilar application to Neupogen last year, and the biosimilar received unanimous support of FDA’s Oncologic Drugs Advisory Committee on January 7, 2015. An important distinction, however, is that the term "interchangeability“ is a higher standard than biosimilarity, and indicates that the biosimilar may be substituted for the reference product without the intervention of the health care provider who prescribed the reference product. Biosimilars can be approved as stand-alone products, but the end goal of this biosimilar pathway is interchangeability--recognition that the new product is essentially "eq...
Source: Policy and Medicine - Category: American Health Authors: Source Type: blogs