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Fed Circuit: No room to improvise on timing of biosimilar notice

By Mari Serebrov
Regulatory Editor

Tuesday, July 5, 2016

It doesn't matter whether a biosimilar sponsor dances the steps choreographed in the BPCIA, the Federal Circuit ruled Tuesday. It still cannot serve the reference biologic maker with the required 180-day notice of commercial marketing until after the FDA licenses the biosimilar.

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