Cimerli™ (ranibizumab-eqrn), a biosimilar product interchangeable with Lucentis® (ranibizumab), will be available in the US on October 3, 2022, according to Coherus BioSciences.
Cimerli, a vascular endothelial growth factor inhibitor, is indicated for the treatment of patients with neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, diabetic retinopathy, and myopic choroidal neovascularization.
An interchangeable product is defined by the Food and Drug Administration (FDA) as a biological agent that is approved based on data demonstrating that it is highly similar to an approved reference product and that there are no clinically meaningful differences between the products. The interchangeable product can be expected to produce the same clinical result as the reference product in any given patient.
Additionally, for patients who receive the medication more than once, the risk in terms of safety or diminished efficacy from alternating or switching between the reference product and the interchangeable biosimilar is not expected to be greater than if just the reference product is used.
The approval of Cimerli was based on a comprehensive analytical, preclinical and clinical program including the phase 3 COLUMBUS-AMD study (ClinicalTrials.gov Identifier: NCT02611778), which compared the efficacy and safety of Cimerli to Lucentis in 477 adults with wet AMD. Results from the study showed that treatment with Cimerli met the primary endpoint demonstrating a mean improvement for best-corrected visual acuity of +5.1 Early Treatment Diabetic Retinopathy Study (ETDRS) letters at week 8 from baseline compared with +5.6 for Lucentis. The safety and immunogenicity profile of Cimerli was found to be comparable to Lucentis.
Cimerli is supplied as a single-dose glass vial designed to deliver 0.05mL of 10mg/mL or 6mg/mL ranibizumab-eqrn solution for intravitreal injection. The product will be commercially available through specialty distributors. The list price will be $1360 and $816 per single-dose vial for the 0.5mg and 0.3mg dosages, respectively.
Coherus to launch Cimerli™ (ranibizumab-eqrn) in the United States on October 3, 2022. News release. Coherus BioSciences, Inc. Accessed September 19, 2022. https://www.globenewswire.com/news-release/2022/09/19/2518203/33333/en/Coherus-to-Launch-CIMERLI-ranibizumab-eqrn-in-the-United-States-on-October-3-2022.html