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's Neulasta and Neupogen biosimilars do not infringe Amgen's patent, showing sponsors can get around innovator's manufacturing process patents.
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 Supreme Court has called for the Solicitor General's views in litigation between Amgen Inc. and Sandoz Inc. over the biosimilar launch notification and patent dance provisions of the biosimilars statute1. The request indicates the court is interested in the issue and may take it up.