FDAnews Drug Daily Bulletin
Pharmaceuticals / Commercial Operations

Sandoz Requests California Court Make Final Decision in Amgen Biosimilar Case

July 6, 2017
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Following the U.S. Supreme Court’s defining decision on the biosimilar “patent dance” and approval process, Sandoz has requested that an unresolved part of its case against Amgen return to a California federal district court.

The high court ruled last month that Sandoz erred when it did not provide a copy of its biosimilar application to Amgen as required by the Biologics Price Competition and Innovation Act. But the court found those requirements are not enforceable by federal injunction.

The Supreme Court said court injunctions to force disclosure may still be available under state laws, such as through California’s unfair competition statute, and it has sent that question back to the Federal Circuit Court of Appeals, asking the court to consider whether California law applies to Sandoz’s case.

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