While not the first FDA-approved biosimilar for Roche’s blockbuster drug Lucentis – that being Biogen and Samsung Bioepis’ Byooviz, approved in September for three indications – it is the first and only biosimilar interchangeable with Lucentis across all five retinal disease indications.
Cimerli – which becomes the 37th biosimilar approval in the US – is expected to become commercially available in early October.
As Coherus’ second product launch, Cimerli marks a ‘strategic inflection point’ for the company with more biosimilars in the pipeline for 2022 and 2023.
Head-to-head study
Cimerli is a vascular endothelial growth factor (VEGF) inhibitor. The retinal indications for which Cimerli is interchangeable are Neovascular (wet) Age-Related Macular Degeneration (AMD), Macular Edema following Retinal Vein Occlusion (RVO), Diabetic Macular Edema (DME), Diabetic Retinopathy (DR), and Myopic Choroidal Neovascularization (mCNV).
The safety and efficacy of the drug comparable to Lucentis was assessed via the COLUMBUS-AMD study, published in the medical journal Ophthalmology.
The head-to-head study saw Cimerli meet its primary endpoint of change from baseline in best corrected visual acuity (BCVA) at week 8 as compared to reference ranibizumab. Secondary endpoints included change from baseline in BCVA at 48 weeks, change from baseline in FCB retinal thickness at 48 weeks, safety and immunogenicity. The overall safety and immunogenicity profile was comparable with Lucentis.
“Cimerli, the only biosimilar product interchangeable with Lucentis across all five indications, will provide both greater treatment access and choice for patients, payors and providers in the U.S. retinal disease community,” said Paul Reider, Chief Commercial Officer of Coherus BioSciences.