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SCOTUS rules biosimilar applicants can provide notice before FDA approval

Michael Loney, New York


The Supreme Court in the Sandoz v Amgen biosimilar case has ruled that an injunction is not available under federal law and an applicant may provide notice before obtaining a licence from the FDA. The ruling is a win for Sandoz, but the case was remanded for the Federal Circuit to rule on whether an injunction is still available under state law

The Supreme Court has ruled on the process for approving biosimilars under the Biologics Price Competition and Innovation Act (BPCIA) for the first time, mostly siding with Sandoz in its dispute with Amgen.

The court said an injunction is not...


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