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Solicitor General, Generics Makers Rally Behind Sandoz in Biosimilar Case

March 2, 2017

The U.S. solicitor general and several generics makers have filed U.S. Supreme Court briefs in support of reversing a Federal Circuit ruling that orders sponsors to wait six months after an FDA approval to launch a biosimilar.

In January, the Supreme Court agreed to hear the case, which centers on whether a 180-day notification to the branded biologics sponsor is mandatory after a biosimilar approval.

Sandoz petitioned the High Court to reverse the Federal Circuit’s decision ordering it to wait 180 days after receiving FDA approval for Zarxio to launch the product, despite giving Amgen prior notice of its intent to market the biosimilar.

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