In another effort towards a developing India and safe conduct of clinical trials, the Indian Government has announced another major initiative to help the biotech industry by formulating the revised guidelines for biosimilars that has become effective from August 15, 2016.
The new Biosimilar Policy, called the “Guidelines on Similar Biologics” is prepared by the Central Drugs Standard Control Organization (hereinafter referred to as ‘CDSCO’) and the Department of Biotechnology (hereinafter referred to as ‘DBT’), and it lays down the regulatory pathway for a Similar Biologic claiming to be Similar to an already authorized Reference Biologic.
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.
These guidelines address the regulatory pathway regarding manufacturing process and safety, efficacy and quality aspects for Similar Biologics. It also addresses the pre-market regulatory requirements including comparability exercise for quality, preclinical and clinical studies and post market regulatory requirements for Similar Biologics.
However, these guidelines are for the general guidance of all stakeholders and are not meant to substitute or rephrase the Rules made under The 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.
CDSCO is the national regulatory authority in India that evaluates safety, efficacy and quality of drugs in the country. DBT through its Review Committee on Genetic Manipulation (RCGM) is responsible for overseeing the development and preclinical evaluation of recombinant DNA derived products.
Presently, several organizations are actively engaged in manufacturing and marketing 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.
Highlights of the Revised Guidelines
A reference biologic, not marketed in India can be licensed in any ICH (International Council on Harmonization) country, i.e., EU, Japan, US, Canada and Switzerland;
Primary and secondary endpoints to be safety and immunogenicity;
Additional non-comparative immunogenicity studies not mandatory if immunogenicity has been evaluated in clinical studies;
If a preapproval study includes more than 100 patients on proposed similar Biologic drug, then the number of patients in phase IV study can be reduced;
Similar Biologics can only be developed against the Reference Biologic that has been approved using a complete data package in India;
The guidelines are applicable on Similar Biologics to be developed in India or imported to India for marketing authorization;
The Similar Biologics manufacturer to develop manufacturing process which yields a comparable quality product in terms of identity, purity and potency to the Reference Biologic;
The data requirements for review of manufacturing process at preclinical submission stage, shall include a complete description of the manufacturing process and also its consequences on product characteristics.
The guidelines in detail can be accessed at