Indian regulatory authorities for biologics, jointly at Department of Biotechnology and Central Drug Standard Control organization in association with the task force comprising Indian biologics manufacturers laid down the regulatory pathway for manufacturing and marketing authorization of similar biologics, claiming to be similar to an already authorized reference biologic. This guidance has come in force from 15 September 2012 in India. This guidance document is a simple abridged process for evaluation of ‘Similar Biologics’ that are approved and marketed either in India, Europe or USA or any other country for more than 4 years.
