FDA Approves First Biosimilar Interchangeable to Lucentis
Coherus BioSciences announced that the FDA has approved Cimerli (ranibizumab-eqrn) as a biosimilar product interchangeable with Lucentis (ranibizumab injection) 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). Cimerli met the FDA’s standards to the reference product, including safety, efficacy and quality.1
“Cimerli, the only biosimilar product interchangeable with Lucentis across all five indications, will provide both greater treatment access and choice for patients, payors and providers in the US retinal disease community,” Paul Reider, Chief Commercial Officer of Coherus BioSciences, said in a company news release. “Coherus is the only company in the $7 billion anti-VEGF ophthalmology market with a demonstrated track record of U.S. commercial biosimilar success. We intend to replicate our Udenyca achievements with a dedicated retina commercial team eager to leverage their experience and in-depth market understanding to drive Cimerli share.”
“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, MD, Professor of Ophthalmology at the Cole Eye Institute/Cleveland Clinic, and an advisor to Coherus, said in the news release. "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."
Denny Lanfear, CEO of Coherus BioSciences added, “The approval of Cimerli and its upcoming launch represent a strategic inflection point for Coherus as we transition to a multi-product revenue stream. Udenyca, our first product, established our track record of success competing in the U.S. biosimilars market. Our upcoming launch of Cimerli and planned launch next year of our third approved product, our Humira biosimilar, Yusimry, will leverage this experience and knowledge. For Coherus, this portfolio is also our source of internally generated capital as we build a leading innovative oncology franchise that will drive our future growth.”
Commercial availability of Cimerli, in both 0.3 mg and 0.5 mg dosages, is planned for early October 2022.
Cimerli is contraindicated in patients with ocular or periocular infections or known hypersensitivity to ranibizumab products or any of the excipients in Lucentis and Cimerli. Hypersensitivity reactions may manifest as severe intraocular inflammation.1
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.
The COLUMBUS-AMD study, published in the highly-regarded medical journal Ophthalmology, was the head-to-head study where Cimerli 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.2 Based on the totality of evidence, Cimerli demonstrates that clinical outcomes are expected to be the same for any given patient across all indications. As an interchangeable biosimilar, Cimerli is not expected to result in safety risk or reduction in efficacy in any way, when substituted for Lucentis.1
References
1. CIMERLI™ (ranibizumab-eqrn) U.S. Prescribing Information, August 2022.
https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761165s000lbl.pdf
2. Holz FG, Oleksy P, Ricci F, et al. Efficacy and Safety of Biosimilar FYB201 Compared with Ranibizumab in Neovascular Age-Related Macular Degeneration. Ophthalmology. 2022;129(1):54-63. doi:10.1016/j.ophtha.2021.04.031.
3. Biosimilar and Interchangeable Biologics: More Treatment Choices: https://www.fda.gov/consumers/consumer-updates/biosimilar-and-interchangeable-biologics-more-treatment-choices