Regeneron filed a Complaint in the US District Court for the Northern District of West Virginia against Celltrion asserting infringement of 38 US aflibercept patents. The allegations relate to Celltrion’s abbreviated Biologics Drug Application (aBLA) filed with the US Food and Drug Administration (FDA) on 30 June 2023 for CT-P42, biosimilar to Regeneron’s Eylea® (aflibercept), an intravitreal treatment for age-related macular degeneration and other VEGF-mediated eye conditions.
The Complaint states that Celltrion has served a Notice of Commercial Marketing and that its aBLA may be approved as soon as 18 May 2024, the regulatory exclusivity expiry date for Regeneron’s Eylea®.
In March, the US PTAB instituted Celltrion’s IPR challenges to two of these patents, US 10,888,601 and US 10,130,681.