Rising biosimilars in the Indian biopharmaceutical industry: emerging challenges and way forward

Biopharmaceuticals have the potential to contribute immensely towards improving the health and quality of life of people. However, there is a gap in the availability of medical services in India and inequality in disseminating health benefits to the poor. Several issues are associated with biopharmaceuticals, such as increasing cost of treatments, access, affordability, safety, efficacy, quality, and intellectual property rights. Hence, the present paper addresses the crucial questions on the emerging challenges in the Indian biopharmaceutical industry regarding the patent cliff and biosimilars. What are the technological and institutional challenges faced by the biosimilars producing firms? Whether biosimilars could meet the regulatory requirements of safety, efficacy, and whether they will meet global regulatory standards? This article further analyses the regulatory pathways for commercial approval of biosimilars.