Biosimilar Launch Notification Delay Remains In The US, Might Not Matter For Newer Products
This article was originally published in SRA
Executive Summary
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.
You may also be interested in...
Biosimilar Litigation: Genentech Avastin Suit Tossed; Janssen Remicade Case Uncertain
US court dismisses Genentech suit over Amgen's patent dance moves; Janssen v. Celltrion trial is postponed as parties fight over Janssen's standing to sue; and Amgen wants to bar AbbVie citizen petition filers from seeing its Amjevita information.
Biosimilar Litigation: Genentech Avastin Suit Tossed; Janssen Remicade Case Uncertain
US court dismisses Genentech suit over Amgen's patent dance moves; Janssen v. Celltrion trial is postponed as parties fight over Janssen's standing to sue; and Amgen wants to bar AbbVie citizen petition filers from seeing its Amjevita information.
Biosimilar Launch Notification: Solicitor General Backs Pre-FDA Approval Notice
Government urges Supreme Court to take up Sandoz’s Zarxio petition challenging Federal Circuit’s interpretation of the biosimilars statue; says it should also review Amgen’s challenge of ruling on patent dance.