Regulatory requirements for biosimilars as per CDSCO in India in comparison with Yemen

This study examines the regulatory requirements for biosimilars in India and Yemen, highlighting similarities and differences between the Central Drugs Standard Control Organization (CDSCO) and the Ministry of Public Health and Population (MOPHP). The regulatory landscape for biosimilars is evolving globally, with varying requirements across countries. This comparative analysis examines the regulatory requirements for biosimilars in India, governed by the Central Drugs Standard Control Organization (CDSCO), and Yemen. A comprehensive review of guidelines, regulations, and approval processes reveals both similarities and differences between the two countries. While both CDSCO and Yemen require a comparability exercise to demonstrate bio similarity, differences exist in the regulatory framework, clinical trial requirements, and approval processes. CDSCO has a separate regulatory framework and abbreviated pathway for biosimilars, whereas Yemen adopts the MOPHP guidelines and has a registration process. This analysis highlights the need for manufacturers to understand the nuances of each market's regulatory requirements to ensure successful approval and commercialization of biosimilars. The findings of this study can inform regulatory agencies, industry stakeholders, and researchers working in the field of biosimilars.