Biosimilars Sandoz Inc. v. Amgen Inc.

Commercial Marketing notice prior to obtaining a license. Here is the link to the official U. S. Supreme Court opinion https://www.supremecourt.gov/opinions/16pdf/15-1039_1b8e.pdf

Held:  An applicant may provide notice of commercial marketing before obtaining a license/approval from FDA.

The Biologics Price Competition and Innovation Act of 2009 (BPCIA or Act) provides an abbreviated pathway for obtaining Food and Drug Administration (FDA) approval of a drug that is biosimilar to a licensed biological product known as the reference product.

Section 262(l)(8)(A) of the  (BPCIA or Act) states that the applicant “shall provide notice to the reference product sponsor not later than 180 days before the date of the first commercial marketing of the bio-logical product licensed under subsection (k).” See 42 U. S. C. §262(k).

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