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Biosimilar Launch Notification Delay Remains In The US, Might Not Matter For Newer Products

 
• By Brenda Sandburg

The US Court of Appeals for the Federal Circuit has ruled that a biosimilar applicant is required to provide 180-day notice of its commercial marketing after Food and Drug Administration approval whether or not it engages in the patent information exchange process laid out in the biosimilar statute1. But the court suggested that notification could be given at the time of tentative approval, which would prevent a marketing delay for biosimilar versions of newer biologics.

The US Court of Appeals for the Federal Circuit has ruled that a biosimilar applicant is required to provide 180-day notice of its commercial marketing after Food and Drug Administration approval whether or not it engages in the patent information exchange process laid out in the biosimilar statute1. But the court suggested that notification could be given at the time of tentative approval, which would prevent a marketing delay for biosimilar versions of newer biologics.

In a unanimous July 5 opinion in Amgen Inc. v. Apotex Inc., a three-judge panel of the Federal Circuit rejected...

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