Al Ani Nizar Abdulateef, Gorial Faiq I, Al-Sulaitti Saad, Humadi Jasmine Abbas, Awadh Nabaa Ihsan, Mounir Mohamed, Dershaby Yasser El, Jones Heather, Sunna Nancy
Rheumatology Unit, Department of Medicine, College of Medicine, University of Baghdad, Baghdad, Iraq,
Rheumatology Unit, Department of Internal Medicine, Al-Basra General Hospital, Al-Basra, Iraq.
Open Access Rheumatol. 2018 Dec 24;11:1-9. doi: 10.2147/OARRR.S176965. eCollection 2019.
Biologic therapies are an important option in the treatment of patients with rheumatic disease. As the development of potential biosimilars increases, many countries are following the guidelines developed by the WHO, European Medicines Agency, or US Food and Drug Administration to create country-specific regulations for the review and approval of these products. Iraq does not yet have such regulations, and this presents a potential safety concern for patients. The analytical, nonclinical, and clinical data requirements for approval of a potential biosimilar are specific and scientifically rigorous. In some countries, products are available that have not met the stringent criteria for biosimilars; they are usually referred to as "intended copies". Frequently, the available data are not sufficient to demonstrate that they are similar in efficacy and safety to the reference product. Thus, safety issues may arise once the product is in use, as was the case with Kikuzubam, an intended copy of rituximab that was withdrawn from the market in Mexico following reports of severe adverse reactions. It is important to implement scientific, evidence-based guidelines for the review, approval, therapeutic use, and monitoring of biosimilars, and to provide training on this topic to healthcare professionals and patients. In this review, we discuss issues related to the use and regulation of biosimilars, and the differences between biosimilars and intended copies. We also provide suggestions for including biosimilars as a treatment option in Iraq.
生物疗法是治疗风湿性疾病患者的重要选择。随着潜在生物类似药的不断研发，许多国家都在遵循世界卫生组织、欧洲药品管理局或美国食品药品监督管理局制定的指南，制定本国关于这些产品审评和批准的具体法规。伊拉克尚未出台此类法规，这给患者带来了潜在的安全隐患。批准一种潜在生物类似药所需的分析、非临床和临床数据要求是特定且科学严谨的。在一些国家，存在未达到生物类似药严格标准的产品；它们通常被称为“意向仿制品”。通常，现有的数据不足以证明它们在疗效和安全性上与参比产品相似。因此，一旦产品投入使用，可能会出现安全问题，墨西哥的利妥昔单抗意向仿制品基库祖单抗（Kikuzubam）就是如此，在有严重不良反应报告后该产品从市场上撤出。对生物类似药的审评、批准、治疗使用和监测实施科学的、循证的指南，并就此主题对医疗保健专业人员和患者进行培训非常重要。在本综述中，我们讨论了与生物类似药的使用和监管相关的问题，以及生物类似药与意向仿制品之间的差异。我们还为在伊拉克将生物类似药纳入治疗选择提供了建议。
