The Central Drugs Standard Control Organiation (CDSCO) will enforce the revised 'guidelines on similar biologics' with effect from August 15, with a view to laying down 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 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,” the CDSCO notice said.

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.

“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 authorization of similar biologics in India,” the guidelines said.

“India has emerged as one of the leading contributors to the world market for similar biologics with the continuous growth. In fact, similar biologics are expected to become the most important economic and therapeutic component of the pharmaceutical market in India. With several companies venturing into this area, a strong need was felt to streamline the regulatory process through a well defined set of guidelines,” secretary to the Ministry of Science and Technology M K Bhan said.

“As a consequence of biopharmaceuticals reaching the end of their patent life, there has been great demand in this new field of development for similar biologics since past few year. The concept of similar biologics has the potential to produce affordable biotech medicine, a need was felt to address issues and challenges particular with respect to products that qualify as similar biologics, similarity with innovative products and establishing appropriate regulatory pathways to ensure cost effective production of these products,” according DCGI Dr G N Singh.