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Biosimilar Launches Depend Mostly On Patents After Supreme Court Ruling

 
• By Brenda Sandburg

US high court says biosimilar sponsors do not have to wait until after FDA approval to start countdown clock for marketing, but patent litigation may impede launches.

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The US Supreme Court has given bosimilar sponsors the opportunity to launch immediately after approval but they still could be delayed by patent battles and strategic considerations.

In its unanimous June 12 opinion in Sandoz Inc. v. Amgen Inc., the court concluded that...

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