FDA approves Coherus’ Cimerli as biosimilar interchangeable with Lucentis for all five indications

Coherus BioSciences has announced that it has received approval from the US Food and Drug Administration (FDA) for its biosimilar Cimerli (ranibizumab-eqrn) as a biosimilar product interchangeable with Lucentis – ranibizumab injection – for all five indications, with 12 months of interchangeability exclusivity.

Cimerli is interchangeable for retinal indications including neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema, diabetic retinopathy and myopic choroidal neovascularisation.

An interchangeable biosimilar is one that meets additional requirements outlined by the law, allowing for the FDA to approve biosimilar and interchangeable biosimilar treatments, and can be substituted without the need for intervention from a health care professional who prescribed the reference product.

Cimerli belongs to the anti-VEGF therapy class of biologics that has helped retinal patients maintain or gain vision, and the product has been subject to the FDA’s rigorous standards to the reference product, which include assessments for safety, efficacy and quality.

The FDA’s decision is based on a comprehensive analytical, preclinical and clinical programme – including the COLUMBUS-AMD study – to confirm equivalent safety and efficacy to Lucentis.

The COLUMBUS-AMD study, published in 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 eight, when 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.

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

Paul Reider, chief commercial officer of Coherus BioSciences, said: “Cimerli, the only biosimilar product interchangeable with Lucentis across all five indications, will provide both greater treatment access and choice for patients, payers and providers in the US retinal disease community.

“Coherus is the only company in the $7bn anti-VEGF ophthalmology market with a demonstrated track record of US 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.”

Commercial availability of Cimerli, in both 0.3mg and 0.5mg dosages, is planned for early October 2022.