What Biologics Price Competition and Innovation Act of 2009 requires
The FDA 351(k) biosimilar pathway requires that an applicant demonstrate biosimilarity to a reference product…
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Pillar: Pharmaceuticals & Life Sciences · Authority: U.S. Food and Drug Administration · Version: 1.0.1 · Last updated:
Primary source: https://www.ecfr.gov/current/title-21/section-601.2
SHA-256 integrity: 625a068ce44a754de8a513bb501e3e9ce367c498ac355ed778f00c063b55627f
Primary Citations — 5 traced to source
- Public Health Service Act, Section 351(k) - Licensure of Biological Products
- 21 CFR 601.2 - Applications for Biological Products
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