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Approval Alert: Formycon’s Aflibercept Biosimilar Approved in US

Jun 28, 2024

On 28 June 2024, Formcyon and Klinge Biopharma GmbH announced that FDA has approved FYB203, biosimilar to Regeneron’s Eylea® (aflibercept) for nAMD, Diabetic Macular Edema, Diabetic Retinopathy and Macular Edema following Retinal Vein Occlusion.  Klinge, which holds the global commercialisation rights for Formycon’s FYB203, will commercialise the biosimilar in the US as AHZANTIVE® (aflibercept-mrbb). 

FYB203 is the third aflibercept biosimilar to be approved in the US, after Samsung Bioepis’ Opuviz and Biocon’s Yesafili® were both approved as biosimilars to Eylea® with interchangeability in May 2024. 

The US launch dates for the biosimilars remain uncertain due to ongoing BPCIA patent litigation brought by Regeneron against FormyconSamsung Bioepis and Biocon (amongst others) regarding aflibercept.  Preliminary injunctions were issued in relation to Formycon’s and Samsung Bioepis’ aflibercept biosimilars on 21 and 14 June 2024, respectively, while a permanent injunction was granted against Biocon on 11 June 2024.