On August 26, 2024, Regeneron filed a BPCIA complaint in the District Court for the District of New Jersey against Sandoz Inc. related to Sandoz’s ENVEEZU (aflibercept-abzv). This is the fifth BPCIA litigation regarding aflibercept, following Regeneron’s litigations against Biocon/Mylan, Samsung Bioepis, and Formycon, and Amgen, which have been consolidated for pretrial proceedings in a multi-district litigation pending in the District Court for the Northern District of West Virginia. Regeneron has asserted 46 patents against Sandoz.
Sandoz’s ENVEEZU (aflibercept-abzv) was approved by the FDA on August 9, 2024.
Stay tuned to Big Molecule Watch for further developments in this case and check out the BPCIA Litigations Tracker for updates on additional BPCIA cases.