Sandoz Inc. and Morrison & Foerster scored a big win for biosimilar producers Monday when the U.S. Supreme Court finally explained what Congress was thinking when it passed the insanely complicated Biosimilar Price Competition and Innovation Act.
Drugmakers who introduce a “highly similar” version of an existing biological drug won on two grounds. They don’t have to wait to get FDA approval before serving the BPCIA’s required 180-day notice on the branded drugmaker. And they can opt out of the BPCIA’s “patent dance” – a complex exchange of disclosures about the biosimilar product and the branded drug patents – without risking a federal injunction.
