The Union health ministry has issued the 'Revised Draft Guidelines on Similar Biologics' to lay down the regulatory pathway for marketing authorization of similar biologics in the country.

These guidelines, prepared by Central Drugs Standard Control Organization (CDSCO) and the Department of Biotechnology (DBT), address the regulatory pathway regarding manufacturing process and safety, efficacy and quality aspects for similar biologics.  These 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.

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 the 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 Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) country.

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. These guidelines are applicable for similar biologics to be developed in India or imported into the country for marketing authorization.

These guidelines are for the guidance of all stakeholders and are not meant to substitute or rephrase the Rules made under Drugs and Cosmetics Act, 1940 or any other relevant Acts and are subject to being in conformity with the Drugs and Cosmetics Act and Rules as may be amended from time to time.

Presently, several organizations are actively engaged in manufacturing and marketing of similar biologics in India. So far, these similar biologics were approved by 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 the 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 objective of this document is to provide guidelines to applicants to enable them to understand and comply with the regulatory requirements for the market authorization of similar biologics in India.