On 3 December 2025, Fresenius Kabi announced that the FDA has accepted for review Sam Chun Dang’s (SCD) application for its biosimilar aflibercept, SCD411. Under a December 2024 licensing agreement between Fresenius Kabi and SCD, Fresenius has the exclusive rights to commercialise the South Korean developed SCD411, biosimilar to Regeneron’s Eylea® (aflibercept), in the United States, Brazil, Argentina, Chile, Paraguay, Colombia, and Mexico.
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).
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.
On 14 July 2025, Fresenius Kabi filed petitions for IPR (inter partes review) against Regeneron’s US Patent No. 11,084,865 to ophthalmic formulations of aflibercept and US Patent No. 10,828,345 to methods of treating angiogenic eye disorders. Fresenius is seeking to overturn claims 1-5, 7-30, and 32-50 of the 865 patent based on anticipation, and all claims of the 345 patent based on anticipation and obviousness. In November 2025, the PTAB denied institution of the IPR regarding the ‘865 patent on discretionary grounds (without reasons). Fresenius Kabi has sought review of that denial by way of a request filed in December 2025. The IPR regarding the ‘345 patent remains pending.