FDA Approves First Interchangeable Biosimilar to Lucentis

The FDA has approved Cimerli (ranibizumab-eqrn) as a biosimilar product interchangeable with Genentech’s Lucentis (ranibizumab). Coherus BioSciences plans to launch the ophthalmologic therapy in early October 2022.

Cimerli will be available in both 0.3 mg and 0.5 mg dosages and will be interchangeable for all of Lucentis’s indications, including neovascular age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, diabetic retinopathy, and myopic choroidal neovascularization.

“Retinal disease is a significant public health issue with certain conditions leading to vision loss or impairment. As a practitioner committed to the safety and well-being of patients, having an approved biosimilar product that is interchangeable with Lucentis — with a similar safety and efficacy profile — is great news for patients,” Peter K. Kaiser, M.D., professor of Ophthalmology at the Cole Eye Institute/Cleveland Clinic, said in a press release.

Cimerli belongs to the anti-VEGF therapy class of biologics.

The interchangeable approval was based on the COLUMBUS-AMD study to confirm equivalent safety and efficacy to Lucentis. Published in Ophthalmology, this was a head-to-head study where Cimerli met its primary endpoint of change from baseline in best corrected visual acuity (BCVA) at week eight as compared with 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. Based on the totality of evidence, Cimerli demonstrates that clinical outcomes are expected to be the same for any given patient across all indications.

The first biosimilar with interchangeability status compared with its reference product is entitled to one-year of exclusivity of the interchangeability designation.

Coherus didn’t provide a price for Cimerli, but another Lucentis biosimilar, Byooviz, has a list price of $1,130 per single use vial, which is 40% lower than the current list price of Lucentis. Byooviz, developed by Biogen and Samsung Bioepis, launched in June 2022 but it doesn’t have an interchangeable approval. The FDA approved this biosimilar in September 2021 for the treatment of wet macular degeneration, macular edema following retinal vein occlusion, and myopic choroidal neovascularization.

Related: Biogen/Samsung Bioepis Launch the Biosimilar Byooviz