A method for establishing class III medical device equivalence: sodium hyaluronate (GenVisc 850) for the treatment of knee osteoarthritis

Gheorghe Doros,1 Philip T Lavin,2 Michael Daley,3 Larry E Miller4 1School of Public Health, Boston University, Boston, 2Lavin Consulting LLC, Framingham, MA, 3OrthogenRx Inc., Doylestown, PA, 4Miller Scientific Consulting, Inc., Asheville, NC, USA Abstract: Although the concept of equivalence for dr...

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Autores principales:	Doros G, Lavin PT, Daley M, Miller LE
Formato:	article
Lenguaje:	EN
Publicado:	Dove Medical Press 2016
Materias:	Food and Drug Administration generic substantially equivalent biosimilar indistinguishable hyaluronic acid knee Class III medical device osteoarthritis Medical technology R855-855.5
Acceso en línea:	https://doaj.org/article/eeccfd7fe5054b17ad03a8c2b2551875
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spelling	oai:doaj.org-article:eeccfd7fe5054b17ad03a8c2b25518752021-12-02T06:51:02ZA method for establishing class III medical device equivalence: sodium hyaluronate (GenVisc 850) for the treatment of knee osteoarthritis1179-1470https://doaj.org/article/eeccfd7fe5054b17ad03a8c2b25518752016-07-01T00:00:00Zhttps://www.dovepress.com/a-method-for-establishing-class-iii-medical-device-equivalence-sodium--peer-reviewed-article-MDERhttps://doaj.org/toc/1179-1470Gheorghe Doros,1 Philip T Lavin,2 Michael Daley,3 Larry E Miller4 1School of Public Health, Boston University, Boston, 2Lavin Consulting LLC, Framingham, MA, 3OrthogenRx Inc., Doylestown, PA, 4Miller Scientific Consulting, Inc., Asheville, NC, USA Abstract: Although the concept of equivalence for drugs (generics) and biologics (biosimilars) has been readily adopted, the concept of equivalence or indistinguishable characteristics for class III medical devices has yet to be specifically addressed regarding a defined regulatory approval process in the US. In September 2015, GenVisc 850® (sodium hyaluronate), a hyaluronic acid approved for the treatment of knee osteoarthritis, was approved by the US Food and Drug Administration (FDA) based upon indistinguishable characteristics in comparison to an approved branded hyaluronic acid (Supartz®/Supartz FX™). The purpose of this paper is to review the methodology and report the main outcomes used to demonstrate clinical comparability of GenVisc 850 with Supartz/Supartz FX. The FDA approval was collectively attained using prospectively defined methods for preclinical, physical, and chemical testing, as well as noninferiority in clinical performance comparisons. Evidence from five randomized controlled studies of Supartz/Supartz FX vs saline control injections (used for Supartz approval), two randomized controlled trials of GenVisc 850 vs saline control injections, and one randomized controlled study of GenVisc 850 vs Supartz/Supartz FX provided evidence of safety for GenVisc 850. Efficacy was further assessed based on assessment of the same Supartz studies and three prospectively identified GenVisc 850 studies. A Bayesian network meta-analysis was used to demonstrate that the clinical efficacy of GenVisc 850 was noninferior to Supartz/Supartz FX and superior to saline control. Overall, safety of GenVisc 850 was similar to that of Supartz/Supartz FX and saline control injections, while efficacy of GenVisc 850 was noninferior to that of Supartz/Supartz FX and superior to saline control injections. Keywords: Food and Drug Administration, generic, substantially equivalent, biosimilar, indistinguishable, hyaluronic acid, knee, class III, medical device, osteoarthritisDoros GLavin PTDaley MMiller LEDove Medical PressarticleFood and Drug Administrationgenericsubstantially equivalentbiosimilarindistinguishablehyaluronic acidkneeClass IIImedical deviceosteoarthritisMedical technologyR855-855.5ENMedical Devices: Evidence and Research, Vol 2016, Iss Issue 1, Pp 205-211 (2016)
institution	DOAJ
collection	DOAJ
language	EN
topic	Food and Drug Administration generic substantially equivalent biosimilar indistinguishable hyaluronic acid knee Class III medical device osteoarthritis Medical technology R855-855.5
spellingShingle	Food and Drug Administration generic substantially equivalent biosimilar indistinguishable hyaluronic acid knee Class III medical device osteoarthritis Medical technology R855-855.5 Doros G Lavin PT Daley M Miller LE A method for establishing class III medical device equivalence: sodium hyaluronate (GenVisc 850) for the treatment of knee osteoarthritis
description	Gheorghe Doros,1 Philip T Lavin,2 Michael Daley,3 Larry E Miller4 1School of Public Health, Boston University, Boston, 2Lavin Consulting LLC, Framingham, MA, 3OrthogenRx Inc., Doylestown, PA, 4Miller Scientific Consulting, Inc., Asheville, NC, USA Abstract: Although the concept of equivalence for drugs (generics) and biologics (biosimilars) has been readily adopted, the concept of equivalence or indistinguishable characteristics for class III medical devices has yet to be specifically addressed regarding a defined regulatory approval process in the US. In September 2015, GenVisc 850® (sodium hyaluronate), a hyaluronic acid approved for the treatment of knee osteoarthritis, was approved by the US Food and Drug Administration (FDA) based upon indistinguishable characteristics in comparison to an approved branded hyaluronic acid (Supartz®/Supartz FX™). The purpose of this paper is to review the methodology and report the main outcomes used to demonstrate clinical comparability of GenVisc 850 with Supartz/Supartz FX. The FDA approval was collectively attained using prospectively defined methods for preclinical, physical, and chemical testing, as well as noninferiority in clinical performance comparisons. Evidence from five randomized controlled studies of Supartz/Supartz FX vs saline control injections (used for Supartz approval), two randomized controlled trials of GenVisc 850 vs saline control injections, and one randomized controlled study of GenVisc 850 vs Supartz/Supartz FX provided evidence of safety for GenVisc 850. Efficacy was further assessed based on assessment of the same Supartz studies and three prospectively identified GenVisc 850 studies. A Bayesian network meta-analysis was used to demonstrate that the clinical efficacy of GenVisc 850 was noninferior to Supartz/Supartz FX and superior to saline control. Overall, safety of GenVisc 850 was similar to that of Supartz/Supartz FX and saline control injections, while efficacy of GenVisc 850 was noninferior to that of Supartz/Supartz FX and superior to saline control injections. Keywords: Food and Drug Administration, generic, substantially equivalent, biosimilar, indistinguishable, hyaluronic acid, knee, class III, medical device, osteoarthritis
format	article
author	Doros G Lavin PT Daley M Miller LE
author_facet	Doros G Lavin PT Daley M Miller LE
author_sort	Doros G
title	A method for establishing class III medical device equivalence: sodium hyaluronate (GenVisc 850) for the treatment of knee osteoarthritis
title_short	A method for establishing class III medical device equivalence: sodium hyaluronate (GenVisc 850) for the treatment of knee osteoarthritis
title_full	A method for establishing class III medical device equivalence: sodium hyaluronate (GenVisc 850) for the treatment of knee osteoarthritis
title_fullStr	A method for establishing class III medical device equivalence: sodium hyaluronate (GenVisc 850) for the treatment of knee osteoarthritis
title_full_unstemmed	A method for establishing class III medical device equivalence: sodium hyaluronate (GenVisc 850) for the treatment of knee osteoarthritis
title_sort	method for establishing class iii medical device equivalence: sodium hyaluronate (genvisc 850) for the treatment of knee osteoarthritis
publisher	Dove Medical Press
publishDate	2016
url	https://doaj.org/article/eeccfd7fe5054b17ad03a8c2b2551875
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A method for establishing class III medical device equivalence: sodium hyaluronate (GenVisc 850) for the treatment of knee osteoarthritis

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