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

While progress has been made in aligning scientific principles for biosimilar approval, further cooperation through enhanced international regulatory collaboration, standardized data requirements, integrated use of real-world evidence, and transparent communication policies is needed to bridge remaining gaps, facilitat...