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Approval Alert: First Aflibercept Biosimilar Approved in Korea, as Samsung Bioepis’ Afilivu® Gets the Green Light

Feb 26, 2024

On 26 February 2024, Daily Pharm Korea reported that Samsung Bioepis received approval from the Korean Ministry of Food and Drug Safety for Afilivu®, biosimilar to Regeneron’s Eylea® (aflibercept).  This is the first aflibercept biosimilar approved in Korea and Samsung Bioepis’ second biosimilar for ophthalmic disease, after its Lucentis® (ranibizumab) biosimilar – Amelivu® – was approved in Korea in May 2022.  Afilivu® is indicated for treatment of wAMD, RVO, DME and mCNV.   

As previously reported, Samsung Bioepis will co-market Afilivu® in Korea with Samil Pharmaceutical, together with ranibizumab biosimilar Amelivu®. 

In the US, aflibercept biosimilars are the subject of patent infringement litigation commenced by Regeneron against Samsung Bioepis, Amgen, Formycon, Celltrion and Mylan and Biocon.  In Europe, Formycon announced in December 2023 that the EMA had accepted its marketing authorisation application for its aflibercept biosimilar FYB203. Biocon has received marketing approval for its aflibercept biosimilar Yesafili® from the UK Medicines and Healthcare products Regulatory Agency (November 2023) and from the European Commission (September 2023). Formycon announced in December 2023 that the EMA had accepted its application for its aflibercept biosimilar FYB203.