SCOTUS rules biosimilar applicants can provide notice before FDA approval

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SCOTUS rules biosimilar applicants can provide notice before FDA approval

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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

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