FDAnews Drug Daily Bulletin
Pharmaceuticals / Commercial Operations

BIO, Two Drugmakers Side With Amgen in Biosimilar Case

March 30, 2017
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An industry group and two drugmakers have filed U.S. Supreme Court briefs backing Amgen’s request that a Federal Circuit ruling be partially affirmed to mandate that biosimilar makers share information and wait six months after an FDA approval to launch a therapy. 

BIO, Genentech and Janssen have called on the High Court to affirm part of the Federal Circuit’s ruling, in a dispute between Amgen and Sandoz, which said biosimilar makers must give drugmakers a 180-day notice of their intent to launch a biosimilar after receiving an FDA approval.

However, they have also asked the High Court to reverse the part of the ruling that said the information exchange process under the Biologics Price Competition and Innovation Act (BPCIA) is optional — requesting that it become mandatory for biosimilar makers to provide their application and details of their manufacturing processes to branded drugmakers to notify them of potential patent infringement.

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