FDA Rejects Pegfilgrastim (Neulasta) Biosimilar

Novartis kept the news quiet

Novartis has issued its second-quarter report on the company’s financial results. Buried at the bottom of a list of clinical trials is this statement: “Sandoz [a unit of Novartis] has received a complete response letter from the FDA for biosimilar pegfilgrastim candidate (Neulasta). We are working with the agency to address remaining questions.” No further details are given on this previously unknown rejection.

The FDA had accepted the company’s pegfilgrastim biosimilar for review in November 2015. Normally, a standard review takes 10 months. A complete response letter is a communication from the FDA that informs a company that an application cannot be approved in its present form.

Amgen’s pegfilgrastim is a leukocyte growth factor indicated to reduce the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a clinically significant incidence of febrile neutropenia, and to increase survival in patients acutely exposed to myelosuppressive doses of radiation.

Last year, Novartis was the first to win a biosimilar approval in the United States with Zarxio, its copy of Amgen’s filgrastim (Neupogen)––a slightly different formulation of Neulasta.

Sources: FierceBiotech; July 19, 2016; Novartis; July 19, 2016; and Neulasta Prescribing Information; April 2016.