Biologicals And Biosimilars: A Paradigm Shift In Indian Pharmaceutical Healthcare

India has long been recognized as the "Pharmacy of the World" due to its established leadership in affordable generic medicines. However, the rising prevalence of non-communicable diseases such as cancer, diabetes, autoimmune disorders, and chronic inflammatory conditions has created an urgent need for advanced targeted therapies. Biologics and biosimilars are emerging as transformative therapeutic options that significantly improve disease management and patient outcomes. With strong policy support through initiatives such as the Biopharma SHAKTI scheme and the Production Linked Incentive (PLI) programme, India is strategically positioned to transition from a generic-driven pharmaceutical model to a global biologics and biosimilars hub. This review discusses the current clinical need, economic opportunities, regulatory framework, implementation challenges, and future prospects of this strategic shift in the Indian context.