Supreme Court Asks Solicitor General To Weigh In On Biosimilar Case

June 21, 2016 at 5:38 PM
The U.S. Supreme Court on Monday (June 20) invited the Solicitor General to weigh in on a biosimilar court case that, if taken up, could determine whether a biosimilar applicant is required to provide the reference product sponsor their application and related manufacturing information. The case could also determine if the 180-day marketing notification in the biosimilar pathway is only effective after FDA licensure. In March, Sandoz asked the court to take up its high-profile case against Amgen over the...


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