On 15 April 2025, Biocon announced that it has entered a settlement and licence agreement with Regeneron, agreeing to dismiss pending US BPCIA litigation regarding its Eylea® (aflibercept) biosimilar, Yesafili™. The agreement paves the way for a US launch of Yesafili™ (approved May 2024) in the second half of 2026, or earlier under certain undisclosed circumstances.
The US District Court for the Northern District of Virginia had granted a permanent injunction against Biocon on 11 June 2024, preventing the launch of Yesafili™ based on findings of infringement of Regeneron’s US Patent No. 11,084,865 regarding ophthalmic formulations of aflibercept. Biocon filed a Notice of Appeal from the permanent injunction order on 21 June 2024. The appeal of the injunction order, and the substantive proceeding against Biocon involving additional Regeneron patents, have now been dismissed and the permanent injunction has been lifted.
The litigation against Biocon was part of consolidated, multi-district BPCIA litigation brought by Regeneron regarding aflibercept biosimilars against each of Amgen (Pavblu™ approved August 2024), Samsung Bioepis (2 actions; Opuviz™/SB15 approved May 2024), Formycon (Ahzantive®/FYB203 approved June 2024), Celltrion (2 actions, aBLA for CT-P42 submitted to FDA in June 2023) and Sandoz (Enzeevu™ approved August 2024).
Amgen’s Pavblu® was launched in the US in October 2024 following the Court of Appeals for the Federal Circuit’s denial of Regeneron’s application for an injunction earlier in October 2024. However, preliminary injunctions were granted, and remain in place, preventing biosimilar aflibercept launches by Samsung Bioepis (14 June 2024, upheld on appeal on 29 January 2025), Formycon (21 June 2024, upheld on appeal on 29 January 2025) and Celltrion (June-July 2024, upheld on appeal on 5 March 2025). Samsung Bioepis, Formycon and Celltrion are challenging the validity of Regeneron’s ‘865 patent before the USPTO, each having filed a petition for IPR (inter partes review) in November 2024, December 2024 and January 2025, respectively.