India issues a proposed guideline for biosimilars

Currently several organizations are actively engaged in manufacturing and marketing biosimilars (Similar Biologics according to CDSCO wording) in India. So far, these biosimilars were approved by Review Committee on Genetic Manipulation 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 biosimilar to an authorized reference biologic.

According to the new guideline, biosimilars 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 Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) country.

The new guideline which includes several important changes, are open for discussion till 30th of April. You can access the guideline on CDSCO homepage.