Apotex Inc., the largest Canadian owned pharmaceutical company, announced today that the US Food and Drug Administration has accepted for filing the company's application for pegfilgrastim, a biosimilar version of Amgen's Neulasta®. The product has been jointly developed with Intas Pharmaceuticals Ltd. The application was filed under the 351(k) abbreviated approval pathway created by the Biosimilar Price Competition and Innovation Act (BPCIA).

Neulasta is the long acting formulation of Neupogen (filgrastim). Filgrastim is used to help cancer patients taking chemotherapies fight infections and fever by boosting white blood cell counts. Apotex believes it is the first company to have a biosimilar filing accepted for review by FDA for the long acting formulation of the product. According to IMS Health, Neulasta® had approximately $3.6 billion in sales in calendar year 2013.

For more details, go to: http://www.apotex.com/global/about/press/20141217.asp