Sandoz, Inc. v. Amgen, Inc. Post-Decision SCOTUScast

Sandoz, Inc. v. Amgen, Inc. Post-Decision SCOTUScast

From: SCOTUScast
0 0 about 1 year ago
2 Plays 307 Downloads
The Biologics Price Competition and Innovation Act of 2009 (BPCIA) provides an abbreviated pathway for obtaining Food and Drug Administration (FDA) approval of a drug that is biosimilar to an already licensed biological product. Among other things, BPCIA provisions require applicants for approval of a new biosimilar to provide the manufacturer of the already licensed product with a notice of commercial marketing and certain information about the biosimilar. Failure to comply permits the ... See More

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