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BPCIA

SUPREME COURT ALLOWS EARLY NOTICE FOR BIOSIMILARS

Posted at 18:29h June 13, 2017 in Biosimilar, BPCIA by Carlson Caspers
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Yesterday in Sandoz Inc. v. Amgen Inc., et al., the Supreme Court ruled that biosimilar makers may give 180-day notice of sales before product approval, and that the failure of a biosimilar maker to provide its application and manufacturing information to the RLD drug maker under the Biologics Price Competition and Innovation Act (“BPCIA”) is […]

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