Coherus BioSciences, Inc. (NASDAQ: CHRS) has announced approval of CIMERLI (ranibizumab-eqrn), a biosimilar product interchangeable with Lucentis (ranibizumab injection) for all five indications – for 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 approval of CIMERLI and its determination “of interchangeability with Lucentis is based on a comprehensive analytical, preclinical and clinical program (including the COLUMBUS-AMD study) to confirm equivalent safety and efficacy to Lucentis”, according to the company.
CIMERLI (ranibizumab-eqrn), formerly CHS-201 (also known as FYB201), it is a biosimilar to the reference product, Lucentis (ranibizumab) and therefore the same product attributes with Lucentis, in terms of the same dosage strengths (0.3 mg, 0.5 mg), same formulation and excipients, and the same amino acid sequence. CIMERLI is now supported by the results from the COLUMBUS-AMD study, published in the journal Ophthalmology, conducted by a head-to-head study. CIMERLI (FYB201) used the primary end point for a change from baseline in BCVA by ETDRS letters at 8 weeks before the third monthly intravitreal injection. The BCVA improved in both groups, with a mean improvement of +5.1 (FYB201) and +5.6 (reference ranibizumab) with ETDRS letters at week 8. The analysis of covariance (ANCOVA) least squares mean difference for the change from baseline between FYB201 and reference ranibizumab was -0.4 ETDRS letters with a 90% confidence interval (CI) of -1.6 to 0.9. Primary end point was met as the 90% CI was within the predefined equivalence margin. Adverse events were comparable between treatment groups.
Commercial availability of CIMERLI, in both 0.3 mg and 0.5 mg dosages, is planned for early October 2022 and Paul Reider, Chief Commercial Officer of Coherus stated that it “is the only company in the $7 billion anti-VEGF ophthalmology market with a demonstrated track record of U.S. commercial biosimilar success”. In addition, Peter K. Kaiser, MD, Professor of Ophthalmology at the Cole Eye Institute/Cleveland Clinic, and an advisor to Coherus, said that, “[r]etinal 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. Ocular anti-VEGF agents have enabled many people with retinal disease to retain and even gain vision. I am pleased to have an additional treatment option for my patients.”