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In the battle for marketing approval of a biosimilar version of Neupogen under the BPCIA, applicant Sandoz stymied Amgen’s chance to join the so-called patent dance. Andrew Williams of McDonnell Boehnen Hulbert & Berghoff ponders the implications.
On March 6, 2015, the US Food and Drug Administration (FDA) approved an application by Sandoz to market a biosimilar version of Amgen’s Neupogen(filgrastrim) biologic drug. Neupogen is a 175 amino acid recombinant methionyl human granulocyte colony-stimulating factor (r-metHuG-CSF), and is often prescribed for cancer patients on chemotherapy at times when they are at most risk of infection because their white blood cell count is low. Sandoz, a division of Novartis, will market its biosimilar under the brand name Zarxio.
This is the first such application to be approved using the new biosimilar pathway created by the Biologics Price Competition and Innovation Act (BPCIA). Much like with the Hatch-Waxman statute for small-molecule pharmaceuticals, the BPCIA includes both an abbreviated drug approval process and a mechanism by which the parties can address any patent claims while the drug is being approved.
Nevertheless, even though Sandoz chose to avail itself of the first part of the statute, thereby reducing the time and cost required to obtain approval of its drug, it chose not to supply Amgen with a copy of its biosimilar application. This thwarted Amgen’s ability to avail itself of the statutorily-mandated patent exchanges, nicknamed the biosimilar ‘patent dance’.
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Sandoz, Amgen, biosimilar, patent, patent dance, BPCIA