On 2 November 2026, South Korea’s The Financial News, reported that Sam Chun Dang (SCD) has entered into an exclusive sales and supply agreement in Japan with Daiichi Sankyo Espha (DSE) for SCD411, biosimilar to Regeneron/Bayer’s Eylea (aflibercept), 2 mg. In doing so, SCD has terminated an agreement with Senju Pharmaceutical, its existing partner for the aflibercept biosimilar in Japan.
Under the new agreement with DSE, SCD now holds the marketing authorisation in its own name through Japan’s special approval system for foreign manufacturers. This is a change from the previous arrangement in which Senju Pharmaceutical held the marketing authorisation. DSE has responsibility under the agreement for local sales and promotion of SCD411 2 mg pre-filled syringes and vials.
In August 2026, SCD signed a settlement agreement with Regeneron and Bayer to resolve all patent disputes in Europe, Korea and Japan involving SCD411. The financial terms of the settlement have not been disclosed.
SCD411 was approved in vial and pre-filled syringe forms in Japan and Korea in September 2025. It has not yet been launched in Japan but was launched in Korea as Vgenfli™ in December 2025.
In Europe, SCD411 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, SCD’s commercialisation partner under an August 2023 agreement, settled their Canadian aflibercept litigation in June 2024. Health Canada approved SCD411 as Aflivu™ in June 2025 and it was launched in July 2025.