FDA Accepts the First Biosimilar Application under the BPCIA
- Paul A. Calvo, Ph.D.
- Sterne, Kessler, Goldstein & Fox
Sandoz announced today that the FDA accepted its Biologics License Application (BLA) for filgrastim. This marks the first acceptance of a biosimilars application (351(k)) filed under the pathway created by the Biologics Price Competition and Innovation Act of 2009 (BPCIA). Although it has taken four years for the first 351(k) application to be filed, acceptance of Sandoz’s application is the first step towards approval of the first biosimilar biologic in the United States.
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