On 5 December 2025, Korea’s HIT News reported that Samsung Bioepis has successfully overturned a preliminary injunction granted to Regeneron and Bayer which was preventing Korean sales of Samsung Bioepis’ Afilivu® (SB15), biosimilar to Regeneron/Bayer’s Eylea® (aflibercept).
The ruling of the Seoul High Court’s Civil Division, finding in favour of Samsung Bioepis, follows an October 2025 decision of the Korean Patent Court invalidating a Regeneron patent for ophthalmic formulations of aflibercept (the Korean equivalent to US Patent No. 11,084,865).
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. However, that launch was disrupted by the preliminary injunction. Following the appeal decision, Samsung Bioepis/Samil can now resume distribution of Afilivu® in Korea.
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.