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.
References
1. Baca M, Chen Y M-Y, Lowman HB, Presta LG, Wells JA. (1998)
Anti-vegf antibodies.
Patent number: WO1998045331. Assignee: Genentech Inc,. Priority date: 07/04/1997. Publication date: 15/10/1998.
2. Baca M, Chen YM-Y, Lowman HB, Presta LG, Wells JA. (1998)
Anti-vegf antibodies.
Patent number: WO1998045331. Assignee: Genentech Inc.. Priority date: 07/04/1997. Publication date: 15/10/1998.
3. Gaudreault J, Fei D, Rusit J, Suboc P, Shiu V. (2005)
Preclinical pharmacokinetics of Ranibizumab (rhuFabV2) after a single intravitreal administration.
Invest Ophthalmol Vis Sci, 46 (2): 726-33. [PMID:15671306]
4. Sharma A, Reddy P, Kuppermann BD, Bandello F, Lowenstein A. (2018)
Biosimilars in ophthalmology: "Is there a big change on the horizon?".
Clin Ophthalmol, 12: 2137-2143. [PMID:30498330]
5. Woo SJ, Veith M, Hamouz J, Ernest J, Zalewski D, Studnicka J, Vajas A, Papp A, Gabor V, Luu J et al.. (2021)
Efficacy and Safety of a Proposed Ranibizumab Biosimilar Product vs a Reference Ranibizumab Product for Patients With Neovascular Age-Related Macular Degeneration: A Randomized Clinical Trial.
JAMA Ophthalmol, 139 (1): 68-76. [PMID:33211076]