FDLI Update June 2017
4 Pages Posted: 7 Aug 2017
Date Written: July 20, 2017
On June 12, 2017, the Supreme Court decided the highly anticipated first case involving the Biologics Price Competition and Innovation Act (BPCIA). The Supreme Court addressed two related questions: (1) whether the statutory language instructing a biosimilar applicant to provide its application and manufacturing information to the reference biologic sponsor after FDA acceptance of the application is enforceable by injunction; and (2) whether the biosimilar applicant must give notice of intended commercial marketing to the reference biologic sponsor only after obtaining an approved license from the FDA. Upholding the decision of the Federal Circuit on the first question (albeit using different reasoning) and reversing the Federal Circuit on the second question, the Court also introduced some uncertainty for the future. This short article discusses some key points following the decision.
Suggested Citation: Suggested Citation
Paradise, Jordan, Case Note: Sandoz v. Amgen (July 20, 2017). FDLI Update June 2017. Available at SSRN: https://ssrn.com/abstract=3013800