On 30 January 2026, Samsung Bioepis announced that it has secured a settlement and licence agreement with Regeneron and Bayer for the commercialisation of SB15, biosimilar to Eylea® (aflibercept, 2 mg), in countries excluding the US and Canada. The announcement comes a day after Alvotech announced a similar settlement with Regeneron/Bayer on the same molecule.
Samsung Bioepis is permitted to launch SB15 in the UK from January 2026, in Europe from April 2026 and in other countries covered by the agreement (excluding Korea where it is already on the market) from May 2026.
SB15 was the third aflibercept biosimilar to be approved in the EU in November 2024 as Opuviz®, and was approved in the UK under the same brand name in April 2025. The biosimilar received Korean approval (as Afilivu®) in February 2024 and Australian approval (as Opuviz®) in September 2025.
Samsung Bioepis and Regeneron/Bayer have been in litigation regarding aflibercept in multiple countries. In October 2025, the Hague District Court granted an injunction preventing Samsung Bioepis from launching SB15 in the Netherlands. In the UK, Samsung Bioepis defeated an injunction application brought by Regeneron/Bayer in October 2025 and in December 2025, Samsung Bioepis successfully overturned a Korean preliminary injunction.
BPCIA litigation in the US remains on foot. 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 affirmed an earlier decision in June 2024 (US District Court -Northern District of West Virginia), 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.