LUCENTIS (ranibizumab)


Drug overview for LUCENTIS (ranibizumab):

Generic name: RANIBIZUMAB (ra-ni-BIZ-oo-mab)
Drug class: Ophthalmic - Macular Degeneration Agents
Therapeutic class: Ophthalmic Agents

Ranibizumab, a recombinant humanized immunoglobulin G1 kappa (IgG1 kappa) monoclonal antibody fragment, is a vascular endothelial growth factor A (VEGF-A) antagonist. Ranibizumab-nuna and ranibizumab-eqrn are biosimilars to ranibizumab. The FDA defines a biosimilar as a biological product that is highly similar to an FDA-licensed reference biological with the exception of minor differences in clinically inactive components and for which there are no clinically meaningful differences in safety, purity, or potency.

The claim of biosimilarity is based on a totality-of-evidence approach, which includes consideration of data from analytical, animal, and clinical studies (e.g., human pharmacokinetic and pharmacodynamic studies, clinical immunogenicity assessment, additional comparative clinical studies). Therefore, biosimilarity may be established even when there are formulation or minor structural differences as long as these differences are not clinically meaningful. Biosimilars are approved through an abbreviated licensure pathway that establishes biosimilarity between the proposed biological and the reference biological but does not independently establish safety and effectiveness of the proposed biological.

In order to be considered an interchangeable biosimilar, a biological product must meet additional requirements beyond demonstrating biosimilarity to its reference product; these requirements include demonstrating that the biological product can be expected to produce the same clinical results as the reference product in any given patient and, for a biological product that is administered more than once to an individual, the risk in terms of safety or diminished efficacy of alternating or switching between use of the biological product and the reference product is no greater than the risk of using the reference product without such alteration or switch. Biosimilar products that are interchangeable can be substituted for the reference product without the intervention of the healthcare provider who prescribed the reference product. Both of the currently available ranibizumab biosimilars have interchangeable data at this time.

Two ranibizumab biosimilars are available. Biosimilarity of these products has been demonstrated for the indications described in the table below. (See Table 1.) Table 1: Ranibizumab Biosimilar Products and FDA-licensed Indications FDA-labeled indication Ranibizumab-eqrn Ranibizumab-nuna (Cimerli(R)) (Byooviz(R)) Neovascular Age-Related X X Macular Degeneration Macular Edema Following X X Retinal Vein Occlusion Diabetic Macular Edema X Diabetic Retinopathy X Myopic Choroidal X X Neovascularization
DRUG IMAGES
  • LUCENTIS 0.5 MG/0.05 ML SYRING
    LUCENTIS 0.5 MG/0.05 ML SYRING
The following indications for LUCENTIS (ranibizumab) have been approved by the FDA:

Indications:
Branch retinal vein occlusion with macular edema
Central retinal vein occlusion with macular edema
Choroidal neovascularization
Diabetic macular edema
Diabetic retinopathy
Neovascular age-related macular degeneration


Professional Synonyms:
ARMD with choroidal neovascularization
Choroid neovascularization
Diabetic retinitis
Fundus diabeticus
Macular edema following branch retinal vein occlusion (BRVO)
Macular edema following central retinal vein occlusion (CRVO)
Senile macular degeneration with subretinal neovascularization
Senile macular retinal degeneration