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

Authors Al Ani NA, Gorial FI, Al-Sulaitti S, Humadi JA, Awadh NI, Mounir M, El Dershaby Y, Jones H, Sunna N

Received 12 June 2018

Accepted for publication 28 September 2018

Published 24 December 2018 Volume 2019:11 Pages 1—9


Checked for plagiarism Yes

Review by Single anonymous peer review

Peer reviewer comments 3

Editor who approved publication: Professor Chuan-Ju Liu

Nizar Abdulateef Al Ani,1 Faiq I Gorial,1 Saad Al-Sulaitti,2 Jasmine Abbas Humadi,3 Nabaa Ihsan Awadh,4 Mohamed Mounir,5 Yasser El Dershaby,5 Heather Jones,6 Nancy Sunna7

1Rheumatology Unit, Department of Medicine, College of Medicine, University of Baghdad, Baghdad, Iraq; 2Rheumatology Unit, Department of Internal Medicine, Al-Basra General Hospital, Al-Basra, Iraq; 3Rheumatology Unit, Department of Medicine, Al-Nahrain Medical College, Baghdad, Iraq; 4Rheumatology Unit, Department of Internal Medicine, Baghdad Teaching Hospital, Baghdad, Iraq; 5Inflammation & Immunology, Pfizer, Dubai, UAE; 6Inflammation & Immunology, Pfizer, Collegeville, PA, USA; 7Inflammation & Immunology, Pfizer, Amman, Jordan

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issues may arise once the product is in use, as was the case with Kikuzubam, an intended copy of rituximab that was withdrawn from the market in Mexico following reports of severe adverse reactions.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

Keywords: biosimilar, intended copy, Iraq, rheumatology

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