Table 2: Recommendations for use of biosimilars in Saudi Arabia.

1. The introduction of biosimilars in Saudi Arabia should be based on clinical evidence as well as cost considerations.
2. Switching between originator biologics and biosimilars or between different biosimilar products should be a clinical decision made by the treating physician, in collaboration with the patient, on an individual patient basis. Automatic substitution at the pharmacy level is not appropriate.
3. Biosimilar names and labels should be distinguishable from originator biologics and should provide adequate information to ensure appropriate prescribing and dispensing and to track adverse events.
4. Once biosimilars are approved for use, pharmacovigilance must be conducted to monitor their efficacy and long-term safety through post-marketing surveillance, clinical studies, and registry studies.
5. Clinical practice guidelines that incorporate use of biosimilars should be developed for rheumatologists in Saudi Arabia.
6. A local or regional rheumatology society should conduct educational activities to teach stakeholders about biosimilars.

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