Biosimilars and non-medical switching among Saudi rheumatologists. The knowledge gap

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The increasing cost of originator biologicals, combined with consequences of the COVID-19 pandemic, have burdened the healthcare system. Unfortunately, the biosimilar uptake in Saudi Arabia has not reached an optimal level despite the approval of several agents. Therefore, physicians are essential stakeholders in the process and acceptance of biosimilars.

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A previous pilot study that was conducted in the pre-COVID period on Arab rheumatologists showed a low level of understanding of the manufacturing process and approval requirements of biosimilars [1]. The current cross-sectional study aimed to assess the perception toward biosimilars and non-medical switching in members of the Saudi Society for Rheumatology (SSR) through an online survey, which was carried out between 1‒30 November 2020 [2].

A total of 143 of the 249 adult and paediatric rheumatologists registered in the SSR database (57.4%) completed the questionnaire. Of these, only 30.07% and 18.18% reported previous experience of prescribing a biosimilar and performing non-medical switching, respectively.

An adequate level of knowledge about biosimilars was reported by 69 respondents (48.25%). In addition, 69 (48.3%) of participants thought that the current published evidence is adequate to allow extrapolation of biosimilars to all indications approved for the originator biological. However, an adequate understanding of the concept of totality-of-evidence was reported by only 37% of participants. Despite this lack of understanding, 87 participants (60.8%) answered that they are willing to prescribe a biosimilar to an eligible patient.

Paediatric rheumatologists were less likely to agree on the adequacy of data generated in biosimilar programmes to grant extrapolation for non-studied populations, such as children (27% vs. 53% p = 0.014). Almost two thirds (60.1%) of participants believed that non-medical switching can be harmful. On the other hand, 88 (61.5%) believe that non-medical switching can lead to significant cost savings to the healthcare system.

Educational activities are believed by the majority (96.5%) to be best organized by societies rather than pharmaceutical companies due to the high risk of bias. In fact, 112 (78.3%) participants believed that educational activities about biosimilars sponsored by a single pharmaceutical company are biased.

The authors concluded that ‘this initiative has identified critical knowledge gaps regarding the biosimilar approval process and other barriers that likely affect their use by rheumatologists in Saudi Arabia’. They added that it ‘also identified negative views on non-medical switching, which should be the target of future educational activities’.

Conflict of interest
The authors of the research paper [2] reported conflicts of interest, including having received speaker’s honoraria from pharmaceutical companies. For full details of the authors’ conflicts of interest, see the research paper [1].

Abstracted by Mohammed A Omair, Rheumatology Unit, Department of Medicine, King Saud University, Riyadh, Saudi Arabia.

Readers interested to learn more about biosimilars in Saudi Arabia are invited to visit www.gabi-journal.net to view the following manuscript published in GaBI Journal:

Biosimilars in Saudi Arabia: a single-centre, open-label case series examining infliximab switching

Pricing of biosimilars in Saudi Arabia

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References

1. Omair MA, Al Wahshi H, Al Saleh J, et al. Perception toward biosimilars and nonmedical switching: a cross-sectional survey among Arab rheumatologists. Dr Sulaiman Al Habib Medical Journal. 2020;2(4):179-85.
2. Omair MA, Almadany R, Omair MA, et al. Perception of biosimilar biologics and non-medical prescription switching among rheumatologists: a Saudi Society for Rheumatology initiative. Saudi Pharm J. 2022;30(1):39-44.

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