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Synonyms: Fab-12 variant Y0317 | Lucentis® | muMAb VEGF A.4.6.1 | rhuFab V2
ranibizumab is an approved drug (FDA (2006), EMA (2007))
Compound class: Antibody
Comment: Ranibizumab is a Fab fragment of a monoclonal antibody designed to target vascular endothelial growth factor A (VEGFA).
Annotated peptide sequences for this antibody derivative are available from its IMGT/mAb-DB record.
Peptide sequence analysis reveals that ranibizumab sequences are claimed in patent WO1998045331 (clone Y0317) , with an expected affinity similar to clone Y0313-1. It is the Fab fragment of bevacizumab.
Patent protection for originator ranibizumab is expected to expire in 2020 in the US and 2022 in the EU, and biosimilar development is well underway .
Intas Pharmaceuticals launched their Razumab® biosimilar in India in 2015. Samsung Bioepis' SB11 (Byooviz®, ranibizumab-nuna) was EMA approved in August 2021 (FDA approval followed in September 2021), following completion of NCT03150589 . Genentech/Roche's biosimilar Susvimo® (in a refillable ranibizumab-containing ocular implant) was FDA approved for wet AMD in October 2021. Coherus BioSciences announced FDA approval for their biosimilar Cimerli® (ranibizumab-eqrn; formerly FYB201) in August 2022. Cimerli® can be prescribed for all five of the indications for which the reference product is authorised.