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Notice of Intent aBLA

McDonnell Boehnen Hulbert & Berghoff LLP

Genentech, Inc. v. Immunex Rhode Island Corp. (Fed. Cir. 2020)

In a procedurally unusual decision (but one unsurprising in all other respects), the Federal Circuit on Monday affirmed a district court's denial of a temporary restraining order to keep off the market Amgen's biosimilar...more

Fenwick & West LLP

No Exception to Statutory Requirement that a Biosimilar Applicant Provide Notice of Intent to Market its Product

Fenwick & West LLP on

Last week in Amgen Inc. v. Apotex Inc., No. 2016-1308 (Fed. Cir. July 5, 2016), a unanimous Federal Circuit panel ruled that under the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”), a biosimilar applicant...more

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