Supreme Court Rules That Biosimilars Makers Can Give Notice Of Commercial Marketing Before FDA Licensure

Fitzpatrick Case Update
June 12, 2017

In a June 12, 2017 decision authored by Justice Clarence Thomas, the United States Supreme Court in Sandoz v. Amgen ruled that, under the Biologics Price Competition and Innovation Act (BPCIA), biosimilar makers can give notice of commercial marketing before the United States Food and Drug Administration (FDA) licenses their biosimilar products.

The Sandoz ruling resolves an ambiguity in the text of the BPCIA, which gave rise to a presumption by some (and a holding by the Federal Circuit at 794 F.3d 1347, 1358 (2015)) that biosimilar makers had to wait until 180 days after FDA licensure of their biosimilar products before providing notice of the commercial marketing of those products—thereby potentially extending by an additional six months the BPCIA’s statutory 12-year exclusivity period for innovator biologics. The Sandoz ruling makes clear that an additional six-month period of exclusivity was not contemplated by the BPCIA.

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