Health Ministry Issues Guidelines on 'Similar Biologics':  Regulatory Pathway For Marketing Authorization in India

The Union health ministry has issued Guidelines on ‘Similar Biologic’ which will lay down the regulatory pathway for a similar biologic claiming to be similar to an already authorized reference biologic. The guidelines address the regulatory pathway regarding manufacturing process and safety, efficacy and quality aspects for similar biologics.

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.
Any product can be considered as similar biologic only, if it is proven to be similar using extensive quality characterization against the reference biologic. Further product development should only be considered once the similarity of the similar biologic is demonstrated in quality to a reference biologic. The Guidelines are applicable for similar biologics to be developed in India or imported into the country for marketing authorization.

The Guidelines, prepared by Central Drugs Standard Control Organization (CDSCO) and the Department of Biotechnology (DBT), also address the premarket regulatory requirements including comparability exercise for quality, preclinical and clinical studies and post market regulatory requirements for similar biologics.

These guidelines apply to similar biologics that contain well characterized proteins as their active substance, derived through modern biotechnological methods such as use of recombinant DNA technology. The demonstration of similarity depends upon detailed and comprehensive product characterization, preclinical and clinical studies carried out in comparison with a reference biologic. Similar biologic can only be developed against an authorized reference biologic that has been approved using a complete data package in India. In case the reference biologic is not authorized in India, it should have been approved/licensed and marketed in an ICH (The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use) country.

.Based on demonstration of similarity in the comparative assessment, a similar biologic may require reduced pre-clinical and clinical data package as part of submission for market authorization. The objective of this document is to provide guidelines to applicants to enable them to understand and comply with the regulatory requirements for the authorization of similar biologics in India.

Presently, several organizations are actively engaged in manufacturing and marketing similar biologics in India. So far, these similar biologics were approved by Review Committee on Genetic Manipulation (RCGM) and 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.