Biologic Firm Urges Supreme Court To Reject Prenotice FDA Approval Requirement

(April 14, 2017, 9:07 AM EDT) -- WASHINGTON, D.C. — In a March 31 brief, Sandoz Inc. tells the U.S. Supreme Court that rival biologic maker Amgen Inc. and the Federal Circuit U.S. Court of Appeals have improperly read a requirement into a federal biosimilar statute mandating Food and Drug Administration approval of a biologic license application prior to the statute’s required 180-day premarketing notice (Sandoz Inc. v. Amgen Inc., et al.., No. 15-1039 and 15-1195, U.S. Sup.)....