Navigating Regulatory Complexities in Biosimilar Approvals and Imports for Autoimmune Disorder Management: A Comparative Analysis of FDA (US), EMA (EU), and CDSCO (India) Guidelines.

Abstract

Biosimilars offer cost-effective alternatives for autoimmune disorder treatment. However, India's stringent regulatory barriers, including mandatory local trials, unclear interchangeability guidelines, and strict pricing controls, hinder market access. This study conducts a comparative analysis of the FDA (US), EMA (EU), and CDSCO (India) regulatory frameworks, highlighting key differences in approval pathways, post-marketing surveillance, and import regulations. Unlike previous studies, this paper employs a structured SWOT analysis to assess the impact of India's regulatory landscape on biosimilar accessibility. The findings reveal that India's local clinical trial mandates and complex approval processes hinder biosimilar adoption despite prior FDA or EMA approvals. Additionally, the absence of interchangeability guidelines discourages physician confidence, while stringent pricing policies under the Drug Price Control Order (DPCO) reduce manufacturer incentives. To improve biosimilar market penetration, India must streamline regulatory approvals, harmonize clinical trial requirements with international standards, and establish clear interchangeability guidelines. These reforms are essential to enhance the affordability and accessibility of biosimilars in the management of autoimmune disorders.