Fed Circuit erred in Sandoz v Amgen, says solicitor general
The US Court of Appeals for the Federal Circuit erred in holding that biosimilar applicants must give 180 days’ pre-marketing notice after an application has been approved by the US Food and Drug Administration (FDA), according to the acting solicitor general.
If you don't have a login or your access has expired, you will need to purchase a subscription to gain access to this article, including all our online content.
For more information on individual annual subscriptions for full paid access and corporate subscription options please contact us.
To request a FREE 2-week trial subscription, please signup.
NOTE - this can take up to 48hrs to be approved.
For multi-user price options, or to check if your company has an existing subscription that we can add you to for FREE, please email Adrian Tapping at atapping@newtonmedia.co.uk
12 June 2017 The US Supreme Court has ruled that biosimilar applicants may provide notice to the manufacturer before obtaining a licence from the Food and Drug Administration for their biosimilars.
22 February 2017 The Biosimilars Council, a division of the Association for Accessible Medicines (AAM), has filed a brief in support of Sandoz’s petition for certiorari in the pending Sandoz v Amgen case.