Review of biologics, biosimilars, and intended copies in rheumatology, and current practice in Iraq.

Abstract

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issues may arise once the product is in use, as was the case with Kikuzubam, an intended copy of rituximab that was withdrawn from the market in Mexico following reports of severe adverse reactions.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.