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
Identifiers and Pagination:Year: 2018
First Page: 313
Last Page: 322
Publisher Id: TORJ-12-313
Article History:Received Date: 27/8/2017
Revision Received Date: 25/10/2018
Acceptance Date: 3/12/2018
Electronic publication date: 31/12/2018
Collection year: 2018
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: (https://creativecommons.org/licenses/by/4.0/legalcode). This license permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
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.