Rheumatology Department, Cairo University, Cairo, Egypt.
Rheumatology Unit, Baghdad College of Medicine, Medical City, Baghdad, Iraq.
Clin Rheumatol. 2018 May;37(5):1143-1152. doi: 10.1007/s10067-018-3982-9. Epub 2018 Feb 6.
The increasing availability of biosimilar medicines in Middle Eastern regions may provide an opportunity to increase the number of rheumatology patients who have access to traditionally more expensive biologic medicines. However, as well as a lack of real-world data on the use of biosimilar medicines in practice, the availability of intended copies in the region may undermine physician confidence in prescribing legitimate biosimilar medicines. There is a need for regional recommendations for healthcare professionals to ensure that biosimilar drugs can be used safely. Therefore, a literature search was performed with the aim of providing important recommendations for the regulation and use of biosimilar medicines in the Middle East from key opinion leaders in rheumatology from the region. These recommendations focus on improving the availability of relevant real-world data, ensuring that physicians are aware of the difference between intended copies and true biosimilars and ensuring that physicians are responsible for making any prescribing and switching decisions.
中东地区越来越多地提供生物类似药，这可能为更多有机会获得传统上更昂贵的生物药物的风湿病患者提供了机会。然而，除了在实践中使用生物类似药的实际数据不足外，该地区预期仿制药的供应情况可能会削弱医生对开处合法生物类似药的信心。需要为医疗保健专业人员提供区域建议，以确保安全使用生物类似药物。因此，进行了文献检索，目的是为该地区的风湿病学关键意见领袖提供有关中东地区生物类似药物监管和使用的重要建议。这些建议侧重于改善相关实际数据的可获得性，确保医生了解预期仿制药与真正的生物类似药之间的区别，并确保医生负责做出任何处方和更换决定。
