Lupin gets CDSCO committee approval for marketing Ranibizumab

Ranibizumab is a recombinant humanized IgG1 kappa isotype monoclonal antibody fragment designed for intraocular use and it is used in the treatment of patients with macular edema after retinal vein occlusion, age-related macular degeneration (wet), and diabetic macular edema.

It acts by binding to human vascular endothelial growth factor A resulting in suppression of the biologic activity of human vascular endothelial growth factor A (VEGF-A).

Ranibizumab is marketed under brand name Lucentis. Lucentis was developed by Roche. The company retains commercial rights in the US and Novartis has exclusive commercial rights for the rest of the world.

The CDSCO Committee thoroughly examined the proposal presented by Lupin, for marketing authorization of said drug at 46th SEC meeting for Ophthalmology, held on 25.06.2021 at CDSCO.

Responding to the Lupin's proposal, after detailed deliberation the committee recommended for grant of approval for marketing, subject to the following condition:

1.The specifications of the drug should be equivalent to the reference product.

2.The firm shall submit Phase IV clinical trial protocol within three months of the grant of marketing authorization.