Comparative Insights into Biosimilar Development in the UAE and India: Opportunities, Challenges, and Global Trends
Authors: Bilkis Khuzema Amthaniwala, Jitesh A. Rathod
Keywords: Biosimilars; United Arab Emirates (UAE); India; Regulatory Framework; Pharmacovigilance; Digital Health; Artificial Intelligence (AI); Market Access; Global Harmonization; Post-COVID Healthcare.
Abstract:
Biosimilars are biological medicines highly similar to approved reference biologics have transformed access to complex therapies by reducing costs and broadening treatment reach. Nearly two decades after the first biosimilar approval, global regulators are increasingly adopting harmonized, evidence-based frameworks that prioritize analytical and pharmacokinetic comparability, reducing the need for extensive clinical efficacy trials. This review examines biosimilar development in the United Arab Emirates (UAE) and India, highlighting regulatory evolution, market growth, and post-COVID policy integration. India has established itself as a global leader, with over 100 approved biosimilars and a market projected to exceed USD 4 billion by 2030, supported by mature frameworks under the Central Drugs Standard Control Organization (CDSCO) and the Department of Biotechnology (DBT). The UAE, meanwhile, is cultivating a dynamic biosimilar ecosystem through regulatory modernization led by the Ministry of Health and Prevention (MOHAP), industrial advancement initiatives, and alignment with WHO and EMA standards. Both countries are leveraging digital transformation to enhance pharmacovigilance, data transparency, and supply-chain resilience. Despite this progress, challenges remain, including regulatory complexity, limited local manufacturing, low market awareness, and unclear interchangeability policies. Yet, the post-COVID landscape presents unprecedented opportunities through AI-enabled bioprocessing, regional regulatory harmonization, and strategic investment in digital health infrastructure. Advancing equitable and sustainable biosimilar adoption in emerging and global markets will require collaborative policy reform, comprehensive stakeholder education, and continued investment in R&D and digital health capacity.
