Biosimilar Pre-Marketing Notice Always Required

Judge Cohn of the U.S. District Court for the Southern District of Florida has issued another decision interpreting the complicated provisions of the Biologics Price Competition and Innovation Action (BPCIA), ruling that the statute requires a biosimilar applicant to give 180 days’ pre-marketing notice after FDA approval even if it has engaged in the BPCIA’s patent dance. The decision came in an order granting Amgen’s motion for a preliminary injunction in Amgen, Inc. v. Apotex Inc. where the biosimilar at issue relates to Amgen’s Neulasta® (pegfilgrastim) product.

The Neulasta® Biosimilar Dispute

Apotex has filed a Biologic License Application (BLA) seeking FDA approval to market a biosimilar version of Amgen's Neulasta® (pegfilgrastim) product. The parties have exchanged information and statements under the “patent dance” provisions of the BPCIA, and, pursuant to those provisions, Amgen filed suit alleging that Apotex’s biosimilar product will infringe two of its