Perception of Biosimilar Biologics and Non-Medical Prescription Switching among Rheumatologists: A Saudi Society for Rheumatology Initiative

Mohammed A Omair; Rana Almadany; Maha A Omair; Hanan Al Rayes; Haya M Almalag; Aws Alshamsan

doi:10.1016/j.jsps.2021.10.012

Perception of Biosimilar Biologics and Non-Medical Prescription Switching among Rheumatologists: A Saudi Society for Rheumatology Initiative

Saudi Pharm J. 2022 Jan;30(1):39-44. doi: 10.1016/j.jsps.2021.10.012. Epub 2021 Dec 21.

Authors

Mohammed A Omair¹, Rana Almadany², Maha A Omair³, Hanan Al Rayes⁴, Haya M Almalag⁵, Aws Alshamsan⁶

Affiliations

¹ Rheumatology Unit, Department of Medicine, King Saud University, Riyadh, Saudi Arabia.
² Saudi Food and Drug Authority, Saudi Arabia.
³ Department of Statistics and Operations Research, College of Science, King Saud University, Riyadh, Saudi Arabia.
⁴ Rheumatology Unit, Medicine Department, Prince Sultan Military Medical City, Riyadh, Saudi Arabia.
⁵ Clinical Pharmacy Department, College of Pharmacy, King Saud University, Riyadh, Saudi Arabia.
⁶ Department of Pharmaceutics, College of Pharmacy, King Saud University, Riyadh, Saudi Arabia.

Abstract

Background: The aim of this study was to evaluate rheumatologists' perceptions of biosimilar biologics and Non-Medical Switching (NMS).

Methods: A cross-sectional survey was conducted among registered members of the Saudi Society for Rheumatology. The questionnaire focused on biosimilars and NMS. Logistic regression was performed to ascertain the effect of demographics and practice characteristics on the use of biosimilars and NMS.

Results: Out of 249 SSR members, 143 completed the survey, generating a response rate of 57.4%. Of those (59.44%) were men with a mean (±SD) age and years of practice of 42.3 ± 9.13 and 10.3 ± 8.9, respectively. Rheumatologists managing adult patients (81.82%) and Ministry of Health practice (43.36 %) were the majority of respondents. Previous experience in prescribing a biosimilar was reported by 43 (30.07%) participants, with a higher probability among women (p = 0.015). A total of 26 (18.18%) participants had performed NMS on eligible patients. Adequate knowledge on biosimilars was reported by 69 (48.25%) participants. The adequacy of evidence to grant biosimilar approval for the studied indication and extrapolation to treat other conditions was reported by 88 (61.5%) and 69 (48.3%), respectively. The concept of totality-of-the-evidence was well understood by 37.1%. Biosimilars had been previously used by 43 (30.07) participants in their practice. NMS had been attempted by 26 (18.18), while 86 (60.1%) participants believed that NMS might harm patients.

Conclusion: There is a clear knowledge gap about the biosimilar approval process among adult and pediatric rheumatologists who took part in the survey. In addition, a large number of participants reported having negative opinions about NMS. There is a need to organize SSR-led educational activities, and develop national guidelines regarding biosimilars and NMS.

Keywords: Biosimilars; Non-medical switching; Rheumatoid arthritis; Saudi Arabia.