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.