FDA Declines to Approve Pegfilgrastim Biosimilar
The U.S. Food and Drug Administration (FDA) denied approval to the biosimilar pegfilgrastim candidate developed by Sandoz.
The U.S. Food and Drug Administration (FDA) denied approval to the biosimilar pegfilgrastim candidate developed by Sandoz, a division of Novartis, according to a press release from Novartis.1
Pegfilgrastim is a recombinant human granulocyte colony-stimulating factor (G-CSF) used to reduce the incidence of infection for patients receiving myelosuppressive anti-cancer agents.
"Sandoz received a complete response letter from the FDA for biosimilar pegfilgrastim candidate (Neulasta)," Novartis said in a statement. "We are working with the agency to address remaining questions."
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The application was based on findings from 3 pivotal clinical trials, including 1 pharmacokinetic and pharmacodynamic study in healthy volunteers, and 2 comparative efficacy and safety studies of patients with breast cancer.
In March 2015, the FDA approved Sandoz's filgrastim-sndz, the first biosimilar product approved in the United States.
- Novartis delivered solid Q2 despite full quarter of US Gleevec generic impact; significant positive innovation news strengthens future growth prospects. Novartis website. https://www.novartis.com/news/media-releases/novartis-delivered-solid-q2-despite-full-quarter-us-gleevec-generic-impact. Updated July 19, 2016. Accessed July 21, 2016.