The Food and Drug Administration (FDA) has approved Cimerli™ (ranibizumab-eqrn), a biosimilar product interchangeable with Lucentis® (ranibizumab).
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.
According to the FDA, an interchangeable product is 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. Patients were randomly assigned to receive Cimerli or Lucentis 0.5mg by intravitreal injection every 4 weeks.
Results showed that treatment with Cimerli met the primary endpoint demonstrating a mean improvement in 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.
“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,” said Dr Peter K. Kaiser, Professor of Ophthalmology at the Cole Eye Institute/Cleveland Clinic, and an advisor to Coherus.
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 is expected to be available in the US in October 2022.
- FDA approves Coherus’ Cimerli™ (ranibizumab-eqrn) as the First and only interchangeable biosimilar to Lucentis® for all five indications, with 12 months of interchangeability exclusivity. News release. Coherus BioSciences. Accessed August 3, 2022. https://www.globenewswire.com/news-release/2022/08/02/2490955/33333/en/FDA-Approves-Coherus-CIMERLI-ranibizumab-eqrn-as-the-First-and-Only-Interchangeable-Biosimilar-to-Lucentis-for-All-Five-Indications-with-12-Months-of-Interchangeability-Exclusivity.html
- Holz FG, Olesky P, Ricci F, et al. Efficacy and safety of biosimilar FYB201 compared with ranibizumab in neovascular age-related macular degeneration. Ophthalmology. Published online May 3, 2021. doi:10.1016/j.ophtha.2021.04.031
- Cimerli. Package insert. Coherus BioSciences; 2022. Accessed August 3, 2022. https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761165s000lbl.pdf
This article originally appeared on MPR