On 21 February 2025, Korean Economic Daily reported that Samsung Bioepis has succeed in a patent dispute regarding Afilivu® (SB15), biosimilar to Regeneron’s Eylea® (aflibercept). Regeneron had commenced the proceeding in January 2023 in the Seoul Central District Court seeking to prevent Samsung Bioepis from producing and selling Afilivu® in Korea. However, the Court has now ruled in Samsung Bioepis’ favour, clearing the way for its biosimilar in Korea, at least for now.
Samsung Bioepis may face further hurdles if the decision is appealed or if Regeneron prevails in a second injunction application filed by Regeneron with the same Court last week. The second injunction application requests a sales ban on Afilivu® in Korea for “other reasons” not cited in the KED report.
Afilivu® was the first aflibercept biosimilar approved in Korea in February 2024. In April 2024, it was reported that Samil Pharmaceutical would launch Samsung Bioepis’ aflibercept biosimilar in the Korean market from 1 May 2024.
On 29 January 2025, the US Court of Appeals for the Federal Circuit refused to overturn a preliminary injunction preventing Samsung Bioepis from launching its aflibercept biosimilar in the US without a licence from Regeneron. This ruling affirmed an earlier decision of the US District Court for the Northern District of West Virginia in June 2024, finding that Samsung Bioepis infringed, and had failed to raise a substantial question of invalidity of, Regeneron’s US Patent No. 11,084,865 regarding ophthalmic formulations of aflibercept.