Unveiling Hope: A Snapshot of CDSCO- Approved Monoclonal Antibodies in India

Monoclonal antibodies are type of immune cell, called as B cell which bind to specific targets known as antigens. One of the key advantages is their specificity and targeted action. Monoclonal antibodies play a crucial role in treating wide range of disease including cancer, autoimmune disorder and infectious disease. Origin of monoclonal antibodies in context of drug development are murine, chimeric, humanized and human monoclonal antibodies. The choice of origin significantly influences the drug development process, imparting timelines, costs and regulatory consideration. The FDA, as the primary regulatory authority in the United States, play a pivotal role in monoclonal antibodies drug approval. Variability in production can impart product quality; efficacy Regulatory agencies demand robust post marketing surveillance; monitoring mechanism to detect; address potential safety concern. Monoclonal antibodies market has valued at is anticipated to witness an impressive growth in the forecast period with a CAGR of 16.24% through 2028. In June 2021, Casivimab and Imdevimab are monoclonal antibodies designed to target the membrane spike protein of SARS-CoV-2, the virus responsible for year 2020 pandemic. High production costs, intellectual property barriers, and regulatory complexities contribute to the prohibitive pricing of these drugs, exacerbating healthcare disparities. Exploring innovative production platform, such as plant-based system or microbial fermentation, could significantly reduce production costs. These alternative platforms have the potential to enhance scalability, ease regulatory constraints, and facilitate the production of biosimilar monoclonal antibody drugs, thereby increasing global accessibility india.