Biosimilars in Rheumatic Diseases: Regulatory Guidelines, Efficacy and Safety Implications in Saudi Arabia

Hussein Halabi1, *, Zeyad Al Zahrani2, Ramiz Al Swailem3, Waleed Husain4, Hanan Al Rayes3, 5, Hanan Al Osaimi6, Yasser El Dershaby7, Haytham Mohamed Ahmed8, Mohamed Mounir7, Mohammed A. Omair9
1 Rheumatology Division, Department of Internal Medicine, King Faisal Specialist Hospital & Research Center, Jeddah, Saudi Arabia
2 Rheumatology Division, Department of Medicine, King Khalid National Guard Hospital, Jeddah, Saudi Arabia
3 Department of Medicine, Prince Sultan Military Medical Complex, Riyadh, Saudi Arabia
4 Division of Rheumatology, Hera General Hospital, Mecca, Saudi Arabia
5 Saudi Society for Rheumatology, Riyadh, Saudi Arabia
6 Department of Rheumatology, King Fahd Armed Forces Hospital, Jeddah, Saudi Arabia
7 Inflammation & Immunology, Pfizer, Dubai, UAE
8 Inflammation & Immunology, Pfizer, Jeddah, Saudi Arabia
9 Division of Rheumatology, Department of Medicine, College of Medicine, King Saud University, Riyadh, Saudi Arabia

© 2018 Halabi et al.

open-access license: This is an open access article distributed under the terms of the Creative Commons Attribution 4.0 International Public License (CC-BY 4.0), a copy of which is available at: ( This license permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.

* Address correspondence to this author at the Rheumatology Division, Department of Internal Medicine, King Faisal Specialist Hospital & Research Center, Jeddah, Saudi Arabia; E-mail:



Treatment with biologic drugs has enabled many patients with inflammatory rheumatic disease to achieve disease control. In some areas of the world, limited access to biologic therapies has created a demand for lower cost options such as biosimilars, which are highly similar, but not identical to originator biologics. The safe use of biosimilars requires a scientifically rigorous review process for their approval, and guidelines that aid rheumatologists in their use.


In Saudi Arabia, there are no national or regional guidelines to assist rheumatologists in the proper use of biosimilars in clinical practice, and this may potentially affect the quality of patient care. In this review, we discuss the importance of developing a guidance and the need for healthcare professionals and patients to receive education about biosimilars. We discuss the unique requirements for biosimilar approval, and the differences between biosimilars, originator biologics, and generics. We review important considerations related to biosimilar use, such as switching from originator biologics to biosimilars, switching between different biosimilars, interchangeability, automatic substitution, naming, and pharmacovigilance. We also provide recommendations based on the authors’ expert opinions as rheumatologists to help ensure the appropriate use of biosimilars in Saudi Arabia.


The approval and use of biosimilars must be supported by scientifically sound evidence. Guidelines for the use of biosimilars are needed in Saudi Arabia to aid rheumatologists in making clinical decisions. Additionally, educational resources should be provided to healthcare professionals and patients.

Keywords: Biologics, Biosimilars, Guidelines, Rheumatology, Saudi Arabia, Switch.