Exploring the Adoption of Biosimilars in Saudi Arabia: Regulatory Framework and Healthcare Professional Perceptions

Authors: Abdulkarim Faleh Fihran Alanazi, Bassam saeed alshehri, Mohammed Nasser musfer alqahtani3Mohammed Nasser musfer alqahtani, Shorooq Eid Ayedh Albishi, Bushra abdullah alharbi, Meshari Bashir Rabea Alrashidi

Country: Saudi Arabia

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Abstract: The advent of biosimilars, highly similar versions of approved biological medicines, has revolutionized the pharmaceutical landscape, offering more affordable alternatives to expensive biologic therapies. As Saudi Arabia strives for equitable and sustainable healthcare delivery, the adoption of biosimilars has become a significant focus. This paper explores the current state of biosimilar adoption in Saudi Arabia, examining the regulatory framework and healthcare professionals' perceptions and attitudes. The Saudi Food and Drug Authority (SFDA) has established a comprehensive regulatory framework aligned with international best practices, ensuring biosimilars' safety, efficacy, and quality through rigorous evaluation processes, interchangeability and substitution guidelines, and specific naming and labeling requirements. However, studies have revealed knowledge gaps and mixed perceptions among healthcare professionals regarding biosimilars' long-term safety, efficacy, and interchangeability with reference biologics. Addressing these concerns through comprehensive education, transparent communication, and robust pharmacovigilance systems is crucial for fostering acceptance and appropriate use of biosimilars. Ultimately, a collaborative, multifaceted approach involving regulatory authorities, healthcare professionals, industry stakeholders, and patient organizations is essential for the successful integration of biosimilars in Saudi Arabia.

Keywords: -

Paper Id: 231384

Published On: 2024-02-15

Published In: Volume 12, Issue 1, January-February 2024

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