FDA Approves Coherus’ Cimerli as Interchangeable Biosimilar to Ranibizumab

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Another ranibizumab biosimilar, Byooviz, is approved, but Coherus’ product is the first deemed interchangeable, which involves additional FDA requirements that allow substitution without intervention of the prescribing clinician.

The Coherus biosimilar ranibizumab-eqrn, which references the injectable Lucentis, received FDA approval late Tuesday, bringing more competition to the ophthalmology market after years in which expensive injectable therapies for retinal conditions brought in billions in sales.

The vascular endothelial growth factor (VEGF) inhibitor, to be sold as Cimerli, was desginated as an interchangeable biosimilar across all 5 indications, with 12 months’ exclusivity on interchangeability. Another ranibizumab biosimilar, Byooviz, is approved, but Coherus’ product is the first deemed interchangeable, which involves additional FDA requirements that allow substitution without intervention of the prescribing clinician, subject to state pharmacy laws. Lucentis had sales of $1.61 billion in 2020.

In a statement, Coherus’ Chief Commercial Officer Paul Reider said the status will ensure greater access and choice for patients with retinal disease. “Coherus is the only company in the $7 billion anti-VEGF ophthalmology market with a demonstrated track record of US commercial biosimilar success,” he said.

The company plans to launch Cimerli in October in both 0.3 mg and 0.5 dosages. Retinal indications for which Cimerli is interchangeable are: neovascular (wet) age-related macular degeneration, or AMD; macular edema following retinal vein occlusion, diabetic macular edema, diabetic retinopathy, and myopic choroidal neovascularization.

The product is contraindicated in patients with ocular or periocular infections or known hypersensitivity to ranibizumab products.

In its statement, Coherus said approval and the interchangeable desgination were based on several studies, including the COLUMBUS-AMD study appearing in Ophthalmology. This head-to-head study showed Cimerli met its primary end point of change from baseline in best corrected visual acuity at week 8 compared with the reference ranibizumab.

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