On 26 August 2024, Regeneron filed a BPCIA complaint against Sandoz in the US District Court for the District of New Jersey, asserting infringement of 46 US patents relating to aflibercept. The filing came two weeks after the FDA approved Sandoz’s Enzeevu™ (aflibercept-abzv), biosimilar to Regeneron’s Eylea®, for treatment of nAMD.
Regeneron has previously also sued Samsung Bioepis (2 actions; Opuviz™/SB15 approved May 2024), Biocon (Yesafili™ approved May 2024), Formycon (Ahzantive®/FYB203 approved June 2024), Celltrion (2 actions, aBLA for CT-P42 submitted to FDA in June 2023) and Amgen (aBLA for ABP 938 accepted by FDA in October 2023 and approved in August 2024), in US BPCIA litigation regarding aflibercept biosimilars. Those actions have been consolidated in the US District Court for the Northern District of West Virginia.
On the same day on which Regeneron’s complaint against Sandoz was filed, the action was conditionally transferred (subject to any opposition) to the US District Court for the Northern District of West Virginia for consolidated pre-trial proceedings with Regeneron’s other aflibercept complaints.
In the US, preliminary injunctions were issued in relation to Formycon’s and Samsung Bioepis’ aflibercept biosimilars on 21 and 14 June 2024, respectively, while a permanent injunction was granted against Biocon on 11 June 2024. Both Samsung Bioepis and Formycon lodged appeals from the preliminary injunction orders (on 14 June 2024 and 25 June 2024, respectively). Biocon filed a Notice of Appeal on 21 June 2024.