Federal Circuit Confirms Post-Licensure Notice of Commercial Marketing Is Mandatory in Biosimilar Litigation

On July 5, 2016, a unanimous Federal Circuit panel held that Apotex failed to give Amgen proper notice of commercial marketing required by the Biologics Price Competition and Innovation Act (“BPCIA” or “Biologics Act”)[1] and must wait 180 days after giving Amgen post-licensure notice before commercially marketing its FDA-licensed biosimilar product.[2]  In affirming the district court’s preliminary injunction against Apotex until the end of the 180-day period, the Federal Circuit followed its previous holding in Amgen v. Sandoz,[3] a split-panel decision.  The court reiterated the bright-line rule that a biosimilar applicant must provide notice of commercial marketing to a reference product sponsor after the FDA grants licensure of the biosimilar product and cannot launch its product until 180 days following that post-licensure notice.

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By: Margaux L. Nair, Trevor M. Gates, Peter Giunta, Kenneth C. Liao

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