FDA Approves Coherus’ Interchangeable Biosimilar for Lucentis

FDA has approved Coherus’ Cimerli (ranibizumab-eqrn) as an interchangeable biosimilar for all five indications of Lucentis.

Coherus BioSciences, a biopharmaceutical company, announced that FDA approved Cimerli (ranibizumab-eqrn) as an interchangeable biosimilar for Lucentis (ranibizumab injection) on Aug. 2, 2022. It is the first biosimilar product interchangeable with Lucentis across all five indications.

Ranibizumab-eqrn is an anti-vascular endothelial growth factor (VEGF) therapy biologic, which has been gaining traction in ophthalmology, according to a company press release. It is Coherus' second FDA approved biosimilar, following Udenyca (pegfilgrastim-cbqv), a biosimilar for Neulasta (pegfilgrastim). Coherus plans to release it in early October 2022 in both 0.3 mg and 0.5 mg dosages. Coherus also plans to release an FDA-approved Humira (adalimumab) biosimilar, Yusimry (adalimumab-aqvh), in 2023.

“[Ranibizumab-eqrn] 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, Coherus BioSciences, in the press release. “Coherus is the only company in the $7 billion anti-VEGF ophthalmology market with a demonstrated track record of US commercial biosimilar success.”

“The approval of [ranibizumab-eqrn] and its upcoming launch represent a strategic inflection point for Coherus as we transition to a multi-product revenue stream,” said Denny Lanfear, CEO, Coherus BioSciences, in the press release. “[Pegfilgrastim-cbqv], our first product, established our track record of success competing in the US biosimilars market. Our upcoming launch of [ranibizumab-eqrn] and planned launch next year of our third approved product, our [adalimumab] biosimilar, [adalimumab-aqvh], will leverage this experience and knowledge.”

Source: Coherus BioSciences