ranibizumab   Click here for help

GtoPdb Ligand ID: 6779

Synonyms: Fab-12 variant Y0317 | Lucentis® | muMAb VEGF A.4.6.1 | rhuFab V2
Approved drug
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) [2], with an expected affinity similar to clone Y0313-1. It is the Fab fragment of bevacizumab.

Biosimilars:
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 [4].
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 [5]. 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.
No information available.
Summary of Clinical Use Click here for help
Used to treat macular edema after retinal vein occlusion, age-related (wet) macular degeneration, and diabetic macular edema. Administered by intravitreal injection.
In February 2015, the US FDA expanded approval to include treatment of diabetic retinopathy. FDA approval was further expaned to include myopic choroidal neovascularization (mCNV; a complication of severe near-sightedness that can lead to blindness) in January 2017.
Mechanism Of Action and Pharmacodynamic Effects Click here for help
Binds to and inhibits the biologic activity (neo-vascularisation/vessel permeabiity) of active forms of human vascular endothelial growth factor A [3].
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