Vasukidevi Ramachandran

Harmonization of Biosimilar Regulatory Frameworks for Autoimmune Therapies: A Comparative Assessment of Safety, Efficacy, and Approval Pathways of EMA, FDA, and CDSCO Using Infliximab as a Case Study

Biosimilar drugs are essential to expanding access to affordable treatments for chronic autoimmune diseases, yet regulatory requirements remain complex, with distinct pathways applied by the European Medicines Agency (EMA), the U.S. Food and Drug Administration (FDA), and India’s Central Drugs Standard Control Orga...