India's Central Drugs Standard Control Organization (CDSCO) and the Department of Biotechnology (DBT) have issued proposed guidelines for biosimilars in India. The “Guidelines on Similar Biologic” specify the regulatory pathway for a similar biologic claiming to be similar to an already authorized reference biologic.CDSCO is the national regulatory authority in India that evaluates the safety, efficacy, and quality of drugs in the country. DBT, through the Review Committee on Genetic Manipulation (RCGM) is responsible for overseeing the development and preclinical evaluation of recombinant biologics
According to the proposed guidelines, a similar biologic product is that which is similar in terms of quality, safety, and efficacy to an approved reference biological product based on comparability. The guidelines address the regulatory pathway regarding manufacturing processes, safety, efficacy, and quality for similar biologics. The guidelines also address the pre‐market regulatory requirements, including comparability exercise for quality, preclinical and clinical studies, and post-market regulatory requirements for similar biologics.
Currently, several organizations are actively engaged in manufacturing and marketing similar biologics in India with these products being approved by the RCGM and the CDSCO using an abbreviated version of the pathway applicable to new drugs on a case-by-case basis. Since there are several such products under development in India, both regulatory agencies considered the need to publish a clear regulatory pathway outlining the requirements to ensure comparable safety, efficacy, and quality of a similar biologic to an authorized reference biologic. Based on demonstration of similarity in the comparative assessment, a similar biologic may require reduced preclinical and clinical data package as part of submission for market authorization. The guidelines are intended to enable the applicants to understand and comply with the regulatory requirements for the
authorization of similar biologics in India.