On 23 September 2025, Korea Biomedical Review reported that Sam Chun Dang’s SCD411, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept), was approved in both Japan and Korea in vial and pre-filled syringe (PFS) forms.
The latest approvals follow SCD411’s Canadian approval on 26 June 2025 and European approval in August 2025, also in vial and PFS forms. 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.
Alvotech/Fuji Pharma received Japanese approval for biosimilar aflibercept (AVT06) earlier this month (September 2025). In Korea Samsung Bioepis’ Afilivu® (SB15) (February 2024) and Celltrion’s Eydenzelt® (CT-P42) (May 2024) have been approved.