• FDA Accepts First Application for Biosimilar Product
  • August 5, 2014 | Authors: Laurie A. Clarke; Colleen Heisey; Mark Mansour; Christopher M. Mikson
  • Law Firm: Jones Day - Washington Office
  • In a significant step for generic biologic products, FDA accepted for review the first application for a biosimilar product. If approved, it could be the first biosimilar product to enter the U.S. market under the nearly five-year-old Biologics Price Competition and Innovation Act ("BPCIA"). Last week, Sandoz, a division of Novartis AG, announced that it had submitted, and FDA had accepted for review, an application for approval of a biosimilar version of Neupogen, a filgrastim product made by Amgen Inc. to reduce the risk of infection in cancer patients who experience a drop in infection-fighting white blood cells when undergoing certain treatments.

    Before making a decision on the Sandoz application, FDA will likely establish a naming policy for biosimilar products and determine, specifically, whether a biosimilar must use the same International Nonproprietary Name ("INN") as its reference biological product. Sandoz's product is marketed in other countries and already has its own INN, but the naming debate has been ongoing for some time. The World Health Organization recently considered promoting the use of biological qualifiers for INNs, and earlier this month, a group of pharmacies, health insurers, and pension plans urged FDA not to give unique names to biosimilars, arguing that such a policy would undermine the potential cost savings generated by these generic products.

    Enacted as part of the Affordable Care Act in 2010, the BPCIA created an abbreviated regulatory pathway for biosimilars consisting of a standard, 10-month review process. FDA officials expect to receive several more biosimilar applications this year, and the Agency has been preparing for a ramp-up in reviews. In May 2014, FDA issued its fifth draft guidance on biosimilars, which aims to assist product sponsors with the design and use of clinical pharmacology studies to support a showing of "biosimilarity," or that a proposed therapeutic biological product is similar to its reference product.