European committee issues positive opinion for Eylea biosimilar

The Committee for Medicinal Products for Human Use of the European Medicines Agency granted a positive opinion for Eydenzelt, a biosimilar to Eylea, according to a press release from Celltrion.

Eydenzelt (aflibercept 40 mg/mL) is recommended to treat wet age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema and myopic choroidal neovascularization. A phase 3 randomized, double-masked, parallel-group, multicenter study found that Eydenzelt demonstrated therapeutic equivalence to Eylea (aflibercept, Regeneron) through predefined equivalence criteria as well as similar efficacy, safety and immunogenicity in patients with DME.

The committee also granted a positive opinion for Stoboclo and Osenvelt as biosimilars for Prolia (denosumab, Amgen) and Xgeva (denosumab, Amgen), respectively, and for Avtozma as a biosimilar for RoActemra (tocilizumab, Roche).

“If marketing authorization is granted by the European Commission, Eydenzelt would be one of the first-wave aflibercept biosimilars in Europe,” the release said.

Published by:

Read more about

This post was originally published on this site