Biosimilar Launch Notification May Head Back To Court

Apotex wants Supreme Court to say that firm doesn't have to wait until FDA licensure of its pegfilgrastim and filgrastim biosimilars to provide Amgen 180-day notice of commercial marketing; Solicitor General has yet to weigh in on similar Sandoz petition.

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Apotex Inc. has followed Sandoz in urging the Supreme Court to review an appeals court ruling that delays the launch of a biosimilar until six months after FDA licensure.

Apotex filed a petition on Sept. 9 challenging the US Court of Appeals for the Federal Circuit's decision...

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