FDA Accepts First Biosimilar Application Filed Under Section 351(K) of the Public Health Services Act

On 24 July 2014, over four years after the enactment of the Biologics Price Competition and Innovation Act, the FDA accepted its first biosimilar application from Sandoz Inc. (Sandoz). Sandoz’s application is for a biosimilar version of Amgen Inc.’s (Amgen) Neupogen® (filgrastim). Neupogen® is a pharmaceutical analog of human granulocyte colony stimulating factor that is used to treat neutropenia, a condition where the body does not make enough neutrophils, a type of white blood cell. Amgen’s Neuprogen® is indicated for use by patients receiving strong chemotherapy to reduce their risk of infection. 

Sandoz’s biosimilar application is set to provide future applicants a wealth of information and, significantly, with clarity around the FDA review process. For example, as part of filing its application, Sandoz will be required to engage in an exchange of manufacturing information with Amgen. This to resolve which, if any, of Amgen’s patents that cover Neupogen® will be litigated by the parties and which patents will not be litigated by the parties. As the first biosimilar application to be subjected to these procedures, it will be interesting to see how the information exchange between Sandoz and Amgen plays out and what, if any, litigation arises as a result. Additionally, if Sandoz’s application is approved it should provide clarity regarding the naming convention to use for biosimilars. Currently, there is an ongoing debate as to how biosimilars should be named. The timeliness of the FDA’s decision on Sandoz’s application will indicate whether it will be possible for the FDA to meet its goal of reviewing 70% of new applications within 10 months for fiscal year 2014, as set forth in the FDA’s Biosimilar Biological Product Authorization Performance Goals and Procedures.