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

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, Depart...

Descripción completa

Guardado en:

Detalles Bibliográficos
Autores principales:	Al Ani NA, Gorial FI, Al-Sulaitti S, Humadi JA, Awadh NI, Mounir M, El Dershaby Y, Jones H, Sunna N
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2018
Materias:	biosimilar intended copy Iraq rheumatology Diseases of the musculoskeletal system RC925-935
Acceso en línea:	https://doaj.org/article/e3f7344a70134ec382e62ef244354960
Etiquetas:	Agregar Etiqueta Sin Etiquetas, Sea el primero en etiquetar este registro!

id	oai:doaj.org-article:e3f7344a70134ec382e62ef244354960
record_format	dspace
spelling	oai:doaj.org-article:e3f7344a70134ec382e62ef2443549602021-12-02T07:13:08ZReview of biologics, biosimilars, and intended copies in rheumatology, and current practice in Iraq1179-156Xhttps://doaj.org/article/e3f7344a70134ec382e62ef2443549602018-12-01T00:00:00Zhttps://www.dovepress.com/review-of-biologics-biosimilars-and-intended-copies-in-rheumatology-an-peer-reviewed-article-OARRRhttps://doaj.org/toc/1179-156XNizar 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, rheumatologyAl Ani NAGorial FIAl-Sulaitti SHumadi JAAwadh NIMounir MEl Dershaby YJones HSunna NDove Medical Pressarticlebiosimilarintended copyIraqrheumatologyDiseases of the musculoskeletal systemRC925-935ENOpen Access Rheumatology: Research and Reviews, Vol Volume 11, Pp 1-9 (2018)
institution	DOAJ
collection	DOAJ
language	EN
topic	biosimilar intended copy Iraq rheumatology Diseases of the musculoskeletal system RC925-935
spellingShingle	biosimilar intended copy Iraq rheumatology Diseases of the musculoskeletal system RC925-935 Al Ani NA Gorial FI Al-Sulaitti S Humadi JA Awadh NI Mounir M El Dershaby Y Jones H Sunna N Review of biologics, biosimilars, and intended copies in rheumatology, and current practice in Iraq
description	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
format	article
author	Al Ani NA Gorial FI Al-Sulaitti S Humadi JA Awadh NI Mounir M El Dershaby Y Jones H Sunna N
author_facet	Al Ani NA Gorial FI Al-Sulaitti S Humadi JA Awadh NI Mounir M El Dershaby Y Jones H Sunna N
author_sort	Al Ani NA
title	Review of biologics, biosimilars, and intended copies in rheumatology, and current practice in Iraq
title_short	Review of biologics, biosimilars, and intended copies in rheumatology, and current practice in Iraq
title_full	Review of biologics, biosimilars, and intended copies in rheumatology, and current practice in Iraq
title_fullStr	Review of biologics, biosimilars, and intended copies in rheumatology, and current practice in Iraq
title_full_unstemmed	Review of biologics, biosimilars, and intended copies in rheumatology, and current practice in Iraq
title_sort	review of biologics, biosimilars, and intended copies in rheumatology, and current practice in iraq
publisher	Dove Medical Press
publishDate	2018
url	https://doaj.org/article/e3f7344a70134ec382e62ef244354960
work_keys_str_mv	AT alanina reviewofbiologicsbiosimilarsandintendedcopiesinrheumatologyandcurrentpracticeiniraq AT gorialfi reviewofbiologicsbiosimilarsandintendedcopiesinrheumatologyandcurrentpracticeiniraq AT alsulaittis reviewofbiologicsbiosimilarsandintendedcopiesinrheumatologyandcurrentpracticeiniraq AT humadija reviewofbiologicsbiosimilarsandintendedcopiesinrheumatologyandcurrentpracticeiniraq AT awadhni reviewofbiologicsbiosimilarsandintendedcopiesinrheumatologyandcurrentpracticeiniraq AT mounirm reviewofbiologicsbiosimilarsandintendedcopiesinrheumatologyandcurrentpracticeiniraq AT eldershabyy reviewofbiologicsbiosimilarsandintendedcopiesinrheumatologyandcurrentpracticeiniraq AT jonesh reviewofbiologicsbiosimilarsandintendedcopiesinrheumatologyandcurrentpracticeiniraq AT sunnan reviewofbiologicsbiosimilarsandintendedcopiesinrheumatologyandcurrentpracticeiniraq
_version_	1718399607706222592

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

Ejemplares similares