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Sam Chun Dang’s Biosimilar Aflibercept Approved in EU

Aug 20, 2025

On 20 August 2025, Korea Biomedical Review reported that Sam Chun Dang’s biosimilar of Regeneron/Bayer’s 2mg Eylea® (aflibercept) received European marketing authorisation in both vial and pre-filled syringe forms (PFS).

According to the report, Sam Chun Dang (SCD) considers it may be the first to launch a PFS aflibercept biosimilar in Europe, after being the first to do so in Canada.  SCD intends to launch the product in Europe “once Eylea®’s patents expire” but has not revealed its EU pricing or distribution partners due to contractual restrictions.

In March 2024, SCD entered an agreement with an unnamed distributor to supply SCD-411 (biosimilar aflibercept) in the UK, Belgium, the Netherlands, Norway, Portugal, Sweden, Greece, Ireland, and Finland.  SCD-411 was also the subject of an exclusive distribution agreement reported in November 2023, between SCD and an unnamed distributor, for supply to Austria, Germany, Italy, Spain, and Switzerland.

SCD announced on 2 July 2025 that SCD-411 received product approval from the Canadian Ministry of Health on 26 June 2025, with sales commencing in July 2025.  This announcement was made the same day that Apotex announced that its Aflivu™ (aflibercept) had been approved by Health Canada in pre-filled syringe and vial formats.  While it was reported in August 2023 that SCD had licensed its aflibercept biosimilar to Apotex for Canada, neither Apotex nor SCD have since referred to this relationship.

On 20 December 2024, Fresenius Kabi announced that it had entered into a licensing agreement with SCD to exclusively commercialise SCD-411 in the United States, Brazil, Argentina, Chile, Paraguay, Colombia, and Mexico.

SCD is currently engaged in litigation with Regeneron/Bayer in South Korea relating to Regeneron’s Korean Patent No. 659477.  Regeneron/Bayer filed the lawsuit in January 2024 alleging that SCD’s licence agreement with an unnamed overseas company to supply SCD-411 constituted an infringement of the patent.

Other aflibercept (2mg) biosimilars presently approved in Europe, none of which have yet launched, are: Biocon’s Yesafili® (September 2023), Sandoz’s Afqlir® (November 2024), Samsung Bioepis/Biogen’s Opuviz™ (SB15) (November 2024), Formycon/Klinge’s Baiama® and Ahzantive® (January 2025), Celltrion’s Eydenzelt® (February 2025), and Amgen’s Pavblu® (April 2025).