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. |