On 18 August 2026, Korea Biomedical Review reported that Sam Chun Dang (SCD) signed a settlement agreement with Regeneron and Bayer to resolve all patent disputes in Europe, Korea and Japan involving SCD411, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept) 2 mg. The financial terms of the settlement have not been disclosed.
Under the agreement, the parties will terminate all pending patent proceedings regarding aflibercept in the relevant jurisdictions, including:
- an infringement lawsuit filed by Regeneron against SCD in the Munich Regional Court on 1 April 2026;
- opposition proceedings in the European Patent Office and the Korean Intellectual Property Office concerning Regeneron’s aflibercept patents;
- Korean litigation filed in January 2024 by Regeneron and Bayer in the Seoul Central District Court against SCD and its subsidiary, Optus Pharmaceutical, alleging that SCD’s licence agreement with an unnamed overseas company to supply SCD411 infringed Regeneron’s Korean Patent No. 659477. Regeneron/Bayer were seeking damages and restrictions related to the manufacture and sale of SCD411; and
- Japanese patent proceedings, about which there is little information publicly available.
It does not appear that the settlement addresses the pending Taiwanese patent infringement litigation commenced in February 2026 by Regeneron against the Taiwanese manufacturer of SCD411 (Mycenax Biotech Biopharmaceutical).
SCD411 was approved in vial and pre-filled syringe forms in Japan and Korea in September 2025. It was launched in Korea as Vgenfli™ in December 2025, despite the pending patent infringement litigation commenced by Regeneron and Bayer, as no injunction was in place preventing sales. SCD11 has not yet been launched in Japan, where the product is to be commercialised by Senju Pharmaceutical.
In Europe, SCD11 was approved as Vgenfli™ in August 2025, with Zaklady Farmaceutyczne Polpharma as the marketing authorisation holder. SCD has announced licence agreements with an unnamed distributor for Austria, Germany, Italy, Spain and Switzerland (November 2023), and a further unnamed distributor for the UK, Belgium, Netherlands, Norway, Portugal, Sweden, Greece, Ireland and Finland (March 2024).
SCD and its US exclusive licensee, Fresenius Kabi, settled US aflibercept litigation with Regeneron/Bayer in February 2026. The settlement permits Fresenius to launch SCD411/Vygenfree™ in the US at an undisclosed time. The FDA accepted SCD’s application for SCD411 for review in December 2025 but the biosimilar has not yet been FDA-approved.
Regeneron, Bayer and Apotex, Sam Chun Dang’s commercialisation partner under an August 2023 agreement, settled their Canadian aflibercept litigation in June 2024. Health Canada approved SCD11 as Aflivu™ in June 2025 and it was launched in July 2025.