COMPARISON REGULATORY PATHWAY FOR DEVELOPMENT AND MARKETING AUTHORIZATION OF BIOSIMILAR PRODUCTS IN INDIA AND USA

A biosimilar is a biological product that is highly similar to and has no clinically meaningful differences from an existing approved biological product. Regulatory guidelines are undergoing constant refinement for biosimilar development and approval. Companies and their outsourcing partners who are willing to enter into the biosimilar market should be aware of all the guidelines and challenges with respect to biosimilars so that they can quickly respond to any sort of queries. The prospect of cost savings and efficiency has made the biosimilar market to look attractive however the regulatory, technical and legal challenges remain. To place any medicinal product in market a marketing authorization must be issued by the regulating agency. The United States authorized the Biologics Price Competition and Innovation Act (BPCI) toward the finish of March 2010 to giving an application pathway to follow-on organic items under areas 7001 to 7003 of the Patient Protection and Affordable Care Act and furthermore classified in 42 USC 262(k). In India, Review Committee on Genetic Manipulation (RCGM) and Genetic Engineering Approval Committee (GEAC) of Central Drugs Standard Control Organization (CDSCO) is answerable for the turn of events and preclinical assessment of recombinant biologics drugs The main aim of issuing marketing authorization is to ensure the product is safe, effective and a high-quality medicine is available in the market. The aspiration of this study is to understand and compare the marketing authorization requirements of biosimilar product and in selected markets like US and India Through these comparisons.