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.
This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.
Login to your accountTry before you buy
7 day trial access
Become a subscriber
Or £77 per month
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed
Chairman, Sanofi Aventis UK
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze