The Current Landscape For Developing Biosimilars In India

By Ankita Bhargava, Senior Research Fellow at the Department of Chemical Engineering, Indian Institute of Technology in Delhi, India

The lucrative patents for many top-selling biologics will expire in the next couple of years, opening up opportunities for the introduction of a wide range of biosimilars. These products are defined as complex biotherapeutic molecules that show similarity to their reference products, in terms of quality, safety, and efficacy. In the merging market of India, a mature biosimilar manufacturing ecosystem and regulatory environment have led the way to considerable growth in the country’s biosimilar market, where over 25 biosimilars have been approved and marketed.1 As it moves toward a promising future, it is important to gain an overview of the current regulatory and clinical expectations in India for biosimilar products.