On March 28, 2016, India’s Central Drugs Standard Control Organization released a new guidance for biosimilars. The guideline states that biosimilars can only be compared to either authorized biologics, approved with a complete data package in India, or biologics that have been approved in an ICH (The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) country.
Comments are accepted on this draft guideline until April 30th, 2016.