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Sandoz Aflibercept Biosimilars EU Approved & Formycon/Klinge Biosims Recommended

Nov 15, 2024

On 15 November 2024, Sandoz announced that its Afqlir®, biosimilar to Bayer/Regeneron’s Eylea® (aflibercept), has been approved in Europe for the treatment of nAMD, macular oedema following retinal vein occlusion (RVO), diabetic macular oedema (DME) and myopic choroidal neovascularisation (mCNV).  Afqlir® obtained a positive recommendation from the European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP) in September 2024.  Sandoz expects to launch in Europe in Q4 2025.

Sandoz’s news comes the same day of Formycon’s announcement that the CHMP has issued a positive opinion for its aflibercept biosimilar, FYB203/Baiama®/Ahzantive®, for the same indications as those of Afqlir®.  Klinge Biopharma holds the global commercialisation rights for FYB203 and is the marketing authorisation applicant for Ahzantive® in Europe (Formycon is the applicant for Baiama®).  The positive CHMP opinion follows the EMA’s acceptance of Formycon’s marketing authorisation application (MAA) for FYB203 in December 2023.  Formycon expects to receive marketing authorisation in the second half of January 2025.

Sandoz’s Afqlir® is the second aflibercept biosimilar to be approved in Europe, following the approval of Biocon’s Yesafili® in September 2023 (with UK approval following in November 2023).  Alvotech/Advanz Pharma’s MAA for AVT06 (aflibercept) was accepted by EMA in August 2024.  In July 2024, Altos Biologics announced that it submitted an MAA to the EMA for its aflibercept biosimilar ALT-L9, with marketing approval expected in 2025.  A positive CHMP opinion was adopted for Samsung Bioepis/Biogen’s Opuviz™ in September 2024.

There are currently five aflibercept biosimilars approved in the US: Sandoz’s Enzeevu™ (August 2024), Formycon/Klinge’s Ahzantive®/FYB203 (June 2024), Amgen’s Pavblu™ (August 2024), Biocon’s Yesafili™ (May 2024) and Samsung Bioepis’ Opuviz™/SB15 (May 2024).