Evolution of biosimilar regulation in Saudi Arabia

Joint Event on 18^th European Biosimilars Congress Joint Event on 35^th Annual European Pharma Congress

April 14-15, 2025 Webinar

Ali M Alsamil

Saudi Food and Drug Authority, Saudi Arabia

Posters & Accepted Abstracts: J Biomed Sci

Abstract :

The increasing demand for cost-effective biologic therapies has positioned biosimilars as a critical component of healthcare systems worldwide. In Saudi Arabia, the landscape of biosimilars has evolved significantly, guided by robust regulatory frameworks and advancements in scientific evaluation. This talk will explore the journey of biosimilar regulation in Saudi Arabia, with a focus on the evolution of regulatory requirements for biosimilar approval. The talk will discuss the scientific principles underpinning biosimilar development, including comparability studies, clinical evaluation, and the importance of pharmacovigilance in the postmarketing phase. Emphasis will be placed on the key milestones in the regulatory journey, from the early adoption of international guidelines to the development of tailored national policies that support local needs and innovation. By highlighting the progress made and challenges faced in the biosimilar regulatory landscape, this talk aims to provide a comprehensive understanding of the regulatory strategies that have enabled the integration of biosimilars into Saudi Arabia’s healthcare system. The provide insights into how these efforts align with global trends and contribute to the national vision for enhancing patient access to high-quality, affordable medicines.