Biogenerics-need for regulatory development in India

2^nd International Conference and Exhibition on Pharmaceutical Regulatory Affairs

November 23-24, 2012 Hyderabad International Convention Centre, India

Nagappagari Madhuri, Palleti Lakshmi Prathusha and N. Vishal Kumar Gupta

Posters: Pharmaceut Reg Affairs

Abstract :

Biogenerics are biological products manufactured after expiry of the patent of innovator biopharmaceuticals and these are also called as Biosimilars or ?follow-on biologics?. Globally, a large number of blockbuster bio therapeutic products are going off patent in the next few years. India has a robust pharmaceutical industry including the biopharmaceutical sector which is actively engaged in the production and marketing of biosimilar products. In the less regulated Indian market, there exist many biosimilars, despite the fact that no specific guidelines exist in India for their approval. Biologic drugs are more expensive and are ideal targets for developing cheaper alternatives. Several steps are still needed for India to be perceived as a country that leads the world in providing quality biological products. In India, the focus is primarily on the availability and affordability of life-saving drugs. In this context every product needs to be evaluated on its own merit irrespective of the innovator brand. The formation of the National Biotechnology Regulatory Authority may provide a step in the right direction for regulation of these complex molecules. However, in order to have efficient machinery for initial approval and ongoing oversight with a country-specific focus, cooperation with international authorities for granting approvals and continuous risk-benefit review is essential. In this context attempts are made to find out the current and future market potential for biosimilar products in India. This also reveals the loopholes present in the regulations for controlling the biosimilar market. The next generation of more affordable biological medicines is no longer a distant dream in India, but a present-day reality in European healthcare.

Biography :

Nagappagari Madhuri is a student of JSS College of Pharmacy, JSS University, Mysore, Karnataka, India. She has completed her B. Pharm from JSS College of Pharmacy Mysore during the year 2012. Presently she is pursuing M. Pharm in Industrial Pharmacy in JSS College of Pharmacy Mysore. She has attended various national and international conferences. Her current areas of interest are formulation research and development, Novel drug delivery system.