News: Health Reform WK-EDGE Alerts, LIFE SCIENCES TOP STORY—U.S.: BPCIA’s patent-dance rules clarified; notice allowed before FDA license received


June 12, 2017
...over their filgastim products, and corrected the Federal Circuit’s reasoning in its lower decision—the requirement in the Biologics Price Competition and Innovation Act of 2009 (BPCIA) that applicants provide sponsor with application and manufacturing information is not enforceable with an injunction under federal law... The BPCIA sought to streamline the FDA approval process for biosimilars—similar but not identical to biologics and must be individually approved by the FDA, unlike generic drugs which are identical to the brand-name drug—while also providing a process to address patent issues arising from biosimilar creation... The parties disagreed upon whether the BPCIA requires a biosimilar manufacturer to exchange information with the sponsor, and on the timing of the required notice...
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