FDA approves Cimerli, first interchangeable biosimilar to Lucentis

Yesterday, the US Food and Drug Administration approved Cimerli (ranibizumab-eqrn; FY201) injection, as biosimilar to, and interchangeable with, Lucentis (ranibizumab injection). This is the 37th biosimilar approval in the USA, the agency noted.

Cimerli is a vascular endothelial growth factor (VEGF) inhibitor and is approved for the same indications approved for Lucentis, which is marketed by Novartis (NOVN: VX) and Roche (ROG: SIX).

FYB201 was developed by Bioeq, a joint venture between Poland-based Polpharma Biologics and Germany’s Formycon (LON: OW4N). At the end 2019, Coherus BioSciences (Nasdaq: CHRS) entered into a license agreement for the exclusive commercialization of FYB201 under the brand name Cimerli in the USA.

Commercial availability of Cimerli, in both 0.3mg and 0.5mg dosages, is planned for early October 2022, according to Coherus, whose shares shot up more than 17% to $11.39 in after-hours trading.