FDA accepts regulatory submission for biosimilar pegfilgrastim from Novartis' Sandoz unit

The US Food and Drug Administration has accepted the regulatory submission by Sandoz, the generics division of Novartis (NOVN: VX), for its biosimilar pegfilgrastim.

The Biologics License Application (BLA) was accepted under the 351 (k) pathway for its proposed biosimilar to Neulasta (pegfilgrastim) from Amgen, which is indicated to help reduce the chance of infection due to a low white blood cell count in patients with cancer receiving chemotherapy that can cause fever and a low blood cell count. Sandoz’s biosimilar would be approved for the same indication.

Mark McCamish, head of global biopharmaceutical and oncology injectables development at Sandoz, said: "The FDA's acceptance of our regulatory submission for biosimilar pegfilgrastim - our third biosimilar filed in the US - demonstrates our commitment to expanding patient access to biologics in the US. If approved, physicians will have another high-quality Sandoz treatment option for patients needing granulocyte colony-stimulating factors."