FDA approves first fully interchangeable Lucentis biosim

Aug. 3, 2022

Coherus BioSciences announced that the U.S. FDA has approved Cimerli as a biosimilar product interchangeable with Roche and Novartis’ blockbuster ophthalmology therapy Lucentis for all indications.

According to California-based Coherus, Cimerli is the first and only biosimilar product interchangeable with Lucentis across all five FDA-approved indications — wet age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), diabetic macular edema (DME), diabetic retinopathy and myopic choroidal neovascularization (mCNV).

Last Sept., Samsung Bioepis’ Byooviz became the first Lucentis biosim cleared for sale by the FDA. The drug — which launched on the market last month — was approved for treatment in three indications — wet AMD, RVO and mCNV.

Coherus plans to launch Cimerli in October in both 0.3 mg and 0.5 dosages.