The Department of Biotechnology (DBT) has drafted a set of guidelines for conducting pre-clinical trials of biosimilars in the country. The Department is now waiting for draft notes on clinical trials for biosimilars from the Drug Controller General of India (DCGI) to complete this work on guidelines.

Manufacture and marketing of biosimilars in India are currently governed by the Environment Protection Act of 1970 and the Drugs and Cosmetic Act. Even though biosimilars is regulated under these provisions of these acts, there is no specific set of rules this sector in the country today.

Emphasising on the need to have proper guidelines to regulate the growing biosimilar market, Dr K K Tripathi, advisor, DBT said that his office has been working for some time to provide industry with a unique set of rules that will help them in their growth.

“Through this guideline, we aim to address the seething problem of lack of regulation in biosimilars in the country. The biggest benefactor of this will be the industry as it will give them more credibility in the market. The guidelines on pre-clinical trials have been completed after taking into consideration the recommendations and comments from all stakeholders and associations from the industry.”

It is believed that the market for biosimilars will change significantly by 2015, as many well known biologic drugs are on the verge of patent expiration.

“We are constantly working for the betterment of the industry and that is why we are keen to complete the guidelines on biosimilars fast. However, to complete the work on guidelines we need data on clinical trials from the DCGI, only after that can we proceed further in this,” Dr Tripathi informed.

DBT have been working on the pre clinical guideline from last one and half year. Biosimilars enter the markets when a biodrug patent expires. Unlike generics, biosimilars are not produced chemically but biologically, taking a biotech drug as a reference.