On 1 November 2025, HITNews reported that Samsung Bioepis has overturned a 2024 decision of the Korean Intellectual Property Trial and Appeal Board (IPTAB) which found that a Regeneron patent for ophthalmic formulations of aflibercept (the Korean equivalent to US Patent No. 11,084,865) was valid. The Korean patent has now been invalidated by the First Division of the Korean Patent Court. An injunction granted in May 2025 based on the patent, preventing Korean sales of Samsung Bioepis’ Afilivu® (SB15), biosimilar to Regeneron’s Eylea® (aflibercept), is expected to be lifted.
This latest success for Samsung Bioepis follows a ruling in its favour by the Seoul Central District Court in February 2025, in a proceeding commenced by Regeneron in January 2023 seeking to prevent Samsung Bioepis from producing and selling Afilivu® in Korea.
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.