First Interchangeable Biosimilar to Lucentis Launches

The FDA approved the first fully interchangeable biosimilar to the blockbuster eye disease medication Lucentis (ranibizumab).

Cimerli (ranibizumab-eqrn), Coherus BiosSciences, is interchangeable with Lucentis (ranibizumab injection) for all 5 indications, “meeting the FDA’s rigorous standards to the reference product, including safety, efficacy, and quality,” Coherus said in a news release.¹

Lucentis, indicated for wet age-related macular degeneration (AMD), visual impairment due to choroidal neovascularisation (CNV), visual impairment due to diabetic macular edema (DME), macular edema following retinal vein occlusion (RVO), diabetic retinopathy (DR), and myopic choroidal neovascularization (mCNV), boasted revenue of $2.16 billion in 2021, a 12% spike from 2020.

Coherus expects Cimerli to be available in both dosages, 0.3 mg and 0.5 mg, in October. When asked for comments on the cost of Cimerli, Kelly Perkins, consultant for Red House Communications, told Drug Topics® "We are not commenting on pricing at this time."

The new biosimilar will provide “both greater treatment access and choice for patients, payors and providers in the US retinal disease community,” said Paul Reider, chief commercial officer of Coherus BioSciences.

“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," added Dr. Peter K. Kaiser, professor of ophthalmology at the Cole Eye Institute/Cleveland Clinic in Ohio, and an advisor to Coherus.

"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,” Kaiser added.

The approval of Cimerli and its interchangeability indication was based on

the COLUMBUS-AMD study.² In the head-to-head study, Cimlerli met 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.

“Based on the totality of evidence, Cimerli demonstrates that clinical outcomes are expected to be the same for any given patient across all indications,” Coherus said. "As an interchangeable biosimilar, Cimerli is not expected to result in safety risk or reduction in efficacy in any way, when substituted for Lucentis.”

Although Cimerli is the first interchangeable biosimilar to Lucentis, the biosimilar Byooviz (Biogen and Samsung Bioepis) has been on the market since July. It launched at a 40% discount — $1130 per single-use vial — to Lucentis.

Reference

1. 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. August 2, 2022. Accessed August 3, 2022. https://www.globenewswire.com/news-release/2022/08/02/2490955/0/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
2. Holz F, Oleksy P, Ricci F, et al. Efficacy and safety of biosimilar FYB201 compared with ranibizumab in neovascular age-related macular degeneration. Ophthalmology. 2022 Jan;129(1):54-63. doi: 10.1016/j.ophtha.2021.04.031.