Archives: Biosimilars

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The Supreme Court Delivers a Win for Biosimilar Manufacturers in Sandoz v. Amgen

On June 12, 2017, the Supreme Court issued a unanimous opinion in Sandoz v. Amgen, interpreting key provisions of the Biologics Price Competition and Innovation Act (BPCIA) in favor of biosimilar manufacturers (applicants).[1] In particular, the Court held that (1) a federal injunction is not available to compel biosimilar applicants to disclose application and manufacturing … Continue Reading

Federal Circuit Confirms That the BPCIA Always Requires Post-Licensure Notice

The Federal Circuit answered one of the questions left open by its July 27, 2015, decision in Amgen Inc. v. Sandoz Inc. (Appeal No. 2015-1499): whether the 180-day commercial marketing notice under the Biologics Price Competition and Innovation Act (BPCIA) is mandatory even for a biosimilar applicant that has participated in the so-called patent dance. … Continue Reading