Sun Pharma gets CDSCO committee approval for manufacturing Ranibizumab
New Delhi: In a significant development, the Subject Expert Committee (SEC) functional under the Central Drugs Standard Control Organization (CDSCO) has granted approval to pharma major Sun Pharmaceuticals to manufacture Ranibizumab for the indication, i.e. neovascular age-related macular degeneration (wet AMD).
This approval is subject to condition that the firm should carry out the Phase IV clinical study as per the guidelines for similar biologics.
Further, in accordance with the Phase IV study, the drug maker is directed to submit protocol for conduct of Phase IV study within three months of obtaining the manufacturing license.
This came in line with the proposal presented by the pharmaceutical major Sun Pharma for marketing authorization for Ranibizumab solution for injection 10mg/ml along with the Phase III clinical study report.
Ranibizumab is used to treat various ocular disorders with abnormal growth of blood vessels, such as neovascular (wet) age-related macular degeneration.
Ranibizumab is a recombinant humanized IgG1 kappa isotype monoclonal antibody fragment directed against human vascular endothelial growth factor A (VEGF-A), which is a glycoprotein implicated in the pathophysiology of age-related macular degeneration.
Ranibizumab binds to VEGF-A with high affinity as well as its biologically active forms, such as VEGF165, VEGF121, and VEGF110. Notably, VEGF165 is the most predominant isoform in the human eye that promotes ocular neovascularization. VEGF165 enhances vascular permeability, inhibits apoptosis, and causes endothelial-cell mobilization from the bone marrow and differentiation for angiogenesis.
Ranibizumab binds to the receptor-binding site of VEGF-A, preventing it from binding to its receptors - VEGFR1 and VEGFR2 - that are expressed on the surface of endothelial cells. Ranibizumab thereby attenuates endothelial cell proliferation, vascular leakage, and new blood vessel formation.
Ranibizumab is marketed under brand name Lucentis. Lucentis was developed by Genentech (Subsidiary of Roche) . The company retains commercial rights in the US and Novartis has exclusive commercial rights for the rest of the world.
Last year, the Medical Dialogues Team had reported that in India Lupin Limited had received marketing approval for Ranibizumab from the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) on the condition that the drug's specifications be equivalent to the reference product and that the company submit a Phase IV clinical trial protocol within three months of receiving marketing authorization.
At recent SEC meeting for ophthalmology, held on 07.04.2022 at CDSCO, the expert panel reviewed the proposal presented by the drug maker Sun Pharma for marketing authorization for Ranibizumab solution for injection 10mg/ml along with the Phase III clinical study report.
The committee observed that the firm has submitted head to head comparison, non clinical toxicity, immunogenicity and clinical efficacy data of the drug in comparison with the reference product for the indication under study.
After detailed deliberation, the committee recommended the grant of permission for manufacture of the drug for the indication i.e. neovascular age-related macular degeneration (wet AMD) subject to the condition that the firm should carry out Phase IV clinical study as per the guidelines for similar biologics.
Further, the drug maker is directed that it should submit protocol for conduct of Phase IV study within three months of obtaining the manufacturing license.
With regard to the other indications applied, the committee recommended that the firm should make a separate proposal for consideration after grant of marketing authorization of the drug.
