On 13 March 2026, IAM reported that Regeneron has applied to a US Court to seek discovery of manufacturing-related documents from Sam Chun Dang’s (SCD’s) US subsidiaries for use in its patent infringement litigation in Taiwan regarding SCD’s biosimilar to Regeneron’s Eylea® (aflibercept), 2mg. Regeneron has made the application for Section 1782 discovery under US legislation that permits a party involved in non-US legal proceedings to obtain documents from a company residing in the US under relevant circumstances.
The Taiwanese patent infringement litigation was commenced by Regeneron in February 2026 against the Taiwanese manufacturer of SCD’s aflibercept biosimilar, SCD411.
Regeneron and Sam Chun Dang settled their US aflibercept litigation in February 2026. In the US, SCD has granted exclusive commercialisation rights for SCD411 to Fresenius Kabi under a December 2024 licence agreement, which also covers Brazil, Argentina, Chile Paraguay, Colombia and Mexico. The settlement permits SCD/Fresenius to launch Vygenfree™/SCD411 in the US at an undisclosed time. Vygenfree™/SCD411 has not yet been approved in the US. The FDA accepted SCD’s application for SCD411 for review in December 2025.
In July 2025, the Seoul Central District Court refused Regeneron/Bayer’s request for an order that SCD submit various documents and information in connection with a lawsuit alleging that SCD’s licence agreement with an unnamed overseas company to supply SCD411 constituted infringement of Regeneron’s Korean Patent 659477.
SCD411 was approved in vial and pre-filled syringe (PFS) forms in Japan and Korea in September 2025, in Canada in June 2025 and in Europe in August 2025. At the time of the European approval, SCD considered it may be the first to launch a PFS aflibercept biosimilar in Europe, after being the first to do so in Canada. SCD reportedly licensed SCD411 to Apotex for the Canadian market (August 2023), to an unnamed distributor for Austria, Germany, Italy, Spain and Switzerland (November 2023), and to a further unnamed distributor for the UK, Belgium, Netherlands, Norway, Portugal, Sweden, Greece, Ireland and Finland (March 2024).