Regulatory requirements for biosimilars as per CDSCO in India in comparison with Yemen
Department of Regulatory Affairs, Sree Siddaganga College of Pharmacy, 1st Left Cross, 3rd Block, Mahalakshmi Nagar, Near Railway Gate, 80 feet Road, Batwadi, Tumkur – 572103. Karnataka, India.
Review Article
World Journal of Advanced Research and Reviews, 2024, 23(03), 2292–2303
Article DOI: 10.30574/wjarr.2024.23.3.2830
Publication history:
Received on 05 August 2024; revised on 18 September 2024; accepted on 20 September 2024
Abstract:
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.
Keywords:
Biosimilars; Regulatory requirements; Yemen; CDSCO; Clinical trials; Approval process1.
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Copyright © 2024 Author(s) retain the copyright of this article. This article is published under the terms of the Creative Commons Attribution Liscense 4.0