Botulinum toxin type A products are not interchangeable: a review of the evidence

Mitchell F Brin,1,2 Charmaine James,3 John Maltman1 1Allergan, Inc., Irvine, CA, USA; 2Department of Neurology, University of California, Irvine, CA, USA; 3Allergan, Marlow, UKAbstract: Botulinum toxin type A (BoNTA) products are injectable biologic medications derived from Clostridium botulinum ba...

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Autores principales:	Brin MF, James C, Maltman J
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2014
Materias:	Medicine (General) R5-920
Acceso en línea:	https://doaj.org/article/171a3c9732204c7aa009be13e0a757e6
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spelling	oai:doaj.org-article:171a3c9732204c7aa009be13e0a757e62021-12-02T11:56:29ZBotulinum toxin type A products are not interchangeable: a review of the evidence1177-5491https://doaj.org/article/171a3c9732204c7aa009be13e0a757e62014-10-01T00:00:00Zhttp://www.dovepress.com/botulinum-toxin-type-a-products-are-not-interchangeable-a-review-of-th-peer-reviewed-article-BTThttps://doaj.org/toc/1177-5491 Mitchell F Brin,1,2 Charmaine James,3 John Maltman1 1Allergan, Inc., Irvine, CA, USA; 2Department of Neurology, University of California, Irvine, CA, USA; 3Allergan, Marlow, UKAbstract: Botulinum toxin type A (BoNTA) products are injectable biologic medications derived from Clostridium botulinum bacteria. Several different BoNTA products are marketed in various countries, and they are not interchangeable. Differences between products include manufacturing processes, formulations, and the assay methods used to determine units of biological activity. These differences result in a specific set of interactions between each BoNTA product and the tissue injected. Consequently, the products show differences in their in vivo profiles, including preclinical dose response curves and clinical dosing, efficacy, duration, and safety/adverse events. Most, but not all, published studies document these differences, suggesting that individual BoNTA products act differently depending on experimental and clinical conditions, and these differences may not always be predictable. Differentiation through regulatory approvals provides a measure of confidence in safety and efficacy at the specified doses for each approved indication. Moreover, the products differ in the amount of study to which they have been subjected, as evidenced by the number of publications in the peer-reviewed literature and the quantity and quality of clinical studies. Given that BoNTAs are potent biological products that meet important clinical needs, it is critical to recognize that their dosing and product performance are not interchangeable and each product should be used according to manufacturer guidelines.Keywords: onabotulinumtoxinA, abobotulinumtoxinA, incobotulinumtoxinA, glabellar lines, non-interchangeabilityBrin MFJames CMaltman JDove Medical PressarticleMedicine (General)R5-920ENBiologics: Targets & Therapy, Vol 2014, Iss default, Pp 227-241 (2014)
institution	DOAJ
collection	DOAJ
language	EN
topic	Medicine (General) R5-920
spellingShingle	Medicine (General) R5-920 Brin MF James C Maltman J Botulinum toxin type A products are not interchangeable: a review of the evidence
description	Mitchell F Brin,1,2 Charmaine James,3 John Maltman1 1Allergan, Inc., Irvine, CA, USA; 2Department of Neurology, University of California, Irvine, CA, USA; 3Allergan, Marlow, UKAbstract: Botulinum toxin type A (BoNTA) products are injectable biologic medications derived from Clostridium botulinum bacteria. Several different BoNTA products are marketed in various countries, and they are not interchangeable. Differences between products include manufacturing processes, formulations, and the assay methods used to determine units of biological activity. These differences result in a specific set of interactions between each BoNTA product and the tissue injected. Consequently, the products show differences in their in vivo profiles, including preclinical dose response curves and clinical dosing, efficacy, duration, and safety/adverse events. Most, but not all, published studies document these differences, suggesting that individual BoNTA products act differently depending on experimental and clinical conditions, and these differences may not always be predictable. Differentiation through regulatory approvals provides a measure of confidence in safety and efficacy at the specified doses for each approved indication. Moreover, the products differ in the amount of study to which they have been subjected, as evidenced by the number of publications in the peer-reviewed literature and the quantity and quality of clinical studies. Given that BoNTAs are potent biological products that meet important clinical needs, it is critical to recognize that their dosing and product performance are not interchangeable and each product should be used according to manufacturer guidelines.Keywords: onabotulinumtoxinA, abobotulinumtoxinA, incobotulinumtoxinA, glabellar lines, non-interchangeability
format	article
author	Brin MF James C Maltman J
author_facet	Brin MF James C Maltman J
author_sort	Brin MF
title	Botulinum toxin type A products are not interchangeable: a review of the evidence
title_short	Botulinum toxin type A products are not interchangeable: a review of the evidence
title_full	Botulinum toxin type A products are not interchangeable: a review of the evidence
title_fullStr	Botulinum toxin type A products are not interchangeable: a review of the evidence
title_full_unstemmed	Botulinum toxin type A products are not interchangeable: a review of the evidence
title_sort	botulinum toxin type a products are not interchangeable: a review of the evidence
publisher	Dove Medical Press
publishDate	2014
url	https://doaj.org/article/171a3c9732204c7aa009be13e0a757e6
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Botulinum toxin type A products are not interchangeable: a review of the evidence

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