FDA Declines Approval of Biosimilar Pegfilgrastim

The U.S. Food and Drug Administration (FDA) declined to approve Sandoz’s (a division of Novartis Pharmaceuticals) biosimilar of Amgen’s pegfilgrastim – a long-acting granulocyte colony stimulating factor for use in boosting white blood cells in patients with cancer who are undergoing chemotherapy.

The agency’s decision was based on results from three pivotal clinical trials on the biosimilar product: one pharmacokinetic and pharmacodynamic study in healthy volunteers and two comparative efficacy and safety studies in patients with breast cancer (PROTECT 1 and 2).

Sandozs said it is working with the FDA to address questions related to the agency’s response letter. In March 2015, the FDA approved Sandoz’s filgrastim-sndz, the first biosimilar product approved in the United States.

Sources: Reuters, July 19, 2016; Fierce Biotech, July 19, 2016.