Scrip is part of the Business Intelligence Division of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

Court Probes Rationale Of Biosimilars' 180-Day Notice

This article was originally published in Scrip

Executive Summary

There was a lot of inside baseball being played at the US Court of Appeals for the Federal Circuit during April 4 oral arguments when Amgen Inc. battled Apotex Inc. over whether Congress intended for it to be mandatory for biosimilar makers to provide 180 days notice of commercial marketing (NCM) to the reference product sponsor (RPS) after the FDA licenses a copycat product.


Related Content

Sandoz's Carol Lynch Highlights Decade Of Biosimilar Dominance And Plans For Many More Winning Years
1Q Earnings Preview: What To Expect From US, EU Big Hitters