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Biosimilar Launch Notification May Head Back To Court

 
• By Brenda Sandburg

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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• By Malcolm Spicer

Bridget Dooling, a law school professor who reviewed draft regulations from the FDA and other agencies as an OMB attorney, said prior federal court decisions suggest judges typically defer to agency decisions based in science.

Europe’s UPC Issues Landmark Ruling On Second Medical Use Claims

 
• By Neena Brizmohun

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UK MHRA: Bacteriophage Developers Wanted ‘More Clarity’ On UK Framework

 
• By Eliza Slawther

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• By Jung Won Shin

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