Is CREATES Act Equipped To Handle Biosimilar Complaints?
Biosimilar sponsors need multiple reference product lots and expiration dates, and questions remain about whether they can obtain enough to fulfill all regulatory requirements under a CREATES Act mandate, Teva attorney says.
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The bill would allow for tentative interchangeable approvals, as well as shared first interchangeable exclusivity for multiple first filers.
Legislation in development also could create an option for tentative approval of interchangeable biosimilars.
Federal Circuit ruling in GSK v. Teva shows brands can broaden a use code to include other patented indications years into litigation, AAM attorney says. The case is ‘scarier’ for biosimilar makers since they must market their products, Teva lawyer notes.