FDA will review Apotex's Neulasta biosimilar

Apotex Inc. (Toronto, Ontario) said FDA accepted for filing a regulatory application for a biosimilar of pegfilgrastim. The application was submitted under the 351(k) abbreviated approval pathway under the Biosimilar Price Competition and Innovation Act (BPCIA).

Pegfilgrastim is a biosimilar version of Neulasta pegylated G-CSF from Amgen Inc. (NASDAQ:AMGN), a long-acting treatment for neutropenia in cancer patients. ...