Changes in Biosimilar Knowledge among European Crohn's Colitis Organization [ECCO] Members: An Updated Survey

Silvio Danese, Gionata Fiorino, Pierre Michetti

Research output: Contribution to journalArticle

Abstract

BACKGROUND: In 2013, a ECCO survey showed that a minority of IBD specialists was aware and confident about the benefits and issues of biosimilars. We aimed to look at the evolution of IBD specialists' thinking about biosimilars one year after they had become available in the European Union.

METHODS: A 14-question anonymous survey was posted on the ECCO website. Members voluntarily responded in response to ECCO office invitations to participate in their surveys. Information on gender, job position, country, and experience with biologics also were collected.

RESULTS: Out of the 118 responders, only 17% of responders had no access to biosimilars. Most responders regarded cost-sparing [92.4%] as the main advantage of biosimilars, considered immunogenicity [69%] to be their main concern, and estimated that post-marketing pharmacovigilance, well-designed randomized clinical trials and further studies of risk profile were needed [30.5%, 27%, 32.2%, respectively, a 30-40% reduction since 2013]. Only 35% of physicians think biosimilars should carry distinct International Nonproprietary Names, as compared with 66% in 2013, and 89.8% disagreed with automatic substitution of the originator with a biosimilar by a pharmacist. The originator and biosimilar were considered interchangeable by 44.4% of responders, as compared with 6% in 2013. Only 32.2% were against the extrapolation across indications, and only 25% would not extrapolate data across IBD. Finally, only 19.5% felt little or no confidence in the use of biosimilars, as compared with 63% in 2013.

CONCLUSION: IBD specialists are generally well informed and educated about biosimilars. Compared with in 2013, there are now fewer concerns and more confidence about their use in clinical practice.

Original languageEnglish
Pages (from-to)1362-1365
Number of pages4
JournalJournal of Crohn's & colitis
Volume10
Issue number11
DOIs
Publication statusPublished - Nov 2016

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Biosimilar Pharmaceuticals
Colitis
Organizations
Pharmacovigilance
Surveys and Questionnaires
European Union
Marketing
Biological Products
Pharmacists

Keywords

  • Journal Article

Cite this

Changes in Biosimilar Knowledge among European Crohn's Colitis Organization [ECCO] Members : An Updated Survey. / Danese, Silvio; Fiorino, Gionata; Michetti, Pierre.

In: Journal of Crohn's & colitis, Vol. 10, No. 11, 11.2016, p. 1362-1365.

Research output: Contribution to journalArticle

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title = "Changes in Biosimilar Knowledge among European Crohn's Colitis Organization [ECCO] Members: An Updated Survey",
abstract = "BACKGROUND: In 2013, a ECCO survey showed that a minority of IBD specialists was aware and confident about the benefits and issues of biosimilars. We aimed to look at the evolution of IBD specialists' thinking about biosimilars one year after they had become available in the European Union.METHODS: A 14-question anonymous survey was posted on the ECCO website. Members voluntarily responded in response to ECCO office invitations to participate in their surveys. Information on gender, job position, country, and experience with biologics also were collected.RESULTS: Out of the 118 responders, only 17{\%} of responders had no access to biosimilars. Most responders regarded cost-sparing [92.4{\%}] as the main advantage of biosimilars, considered immunogenicity [69{\%}] to be their main concern, and estimated that post-marketing pharmacovigilance, well-designed randomized clinical trials and further studies of risk profile were needed [30.5{\%}, 27{\%}, 32.2{\%}, respectively, a 30-40{\%} reduction since 2013]. Only 35{\%} of physicians think biosimilars should carry distinct International Nonproprietary Names, as compared with 66{\%} in 2013, and 89.8{\%} disagreed with automatic substitution of the originator with a biosimilar by a pharmacist. The originator and biosimilar were considered interchangeable by 44.4{\%} of responders, as compared with 6{\%} in 2013. Only 32.2{\%} were against the extrapolation across indications, and only 25{\%} would not extrapolate data across IBD. Finally, only 19.5{\%} felt little or no confidence in the use of biosimilars, as compared with 63{\%} in 2013.CONCLUSION: IBD specialists are generally well informed and educated about biosimilars. Compared with in 2013, there are now fewer concerns and more confidence about their use in clinical practice.",
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T2 - An Updated Survey

AU - Danese, Silvio

AU - Fiorino, Gionata

AU - Michetti, Pierre

N1 - Copyright © 2016 European Crohn’s and Colitis Organisation (ECCO). Published by Oxford University Press. All rights reserved. For permissions, please email: journals.permissions@oup.com.

PY - 2016/11

Y1 - 2016/11

N2 - BACKGROUND: In 2013, a ECCO survey showed that a minority of IBD specialists was aware and confident about the benefits and issues of biosimilars. We aimed to look at the evolution of IBD specialists' thinking about biosimilars one year after they had become available in the European Union.METHODS: A 14-question anonymous survey was posted on the ECCO website. Members voluntarily responded in response to ECCO office invitations to participate in their surveys. Information on gender, job position, country, and experience with biologics also were collected.RESULTS: Out of the 118 responders, only 17% of responders had no access to biosimilars. Most responders regarded cost-sparing [92.4%] as the main advantage of biosimilars, considered immunogenicity [69%] to be their main concern, and estimated that post-marketing pharmacovigilance, well-designed randomized clinical trials and further studies of risk profile were needed [30.5%, 27%, 32.2%, respectively, a 30-40% reduction since 2013]. Only 35% of physicians think biosimilars should carry distinct International Nonproprietary Names, as compared with 66% in 2013, and 89.8% disagreed with automatic substitution of the originator with a biosimilar by a pharmacist. The originator and biosimilar were considered interchangeable by 44.4% of responders, as compared with 6% in 2013. Only 32.2% were against the extrapolation across indications, and only 25% would not extrapolate data across IBD. Finally, only 19.5% felt little or no confidence in the use of biosimilars, as compared with 63% in 2013.CONCLUSION: IBD specialists are generally well informed and educated about biosimilars. Compared with in 2013, there are now fewer concerns and more confidence about their use in clinical practice.

AB - BACKGROUND: In 2013, a ECCO survey showed that a minority of IBD specialists was aware and confident about the benefits and issues of biosimilars. We aimed to look at the evolution of IBD specialists' thinking about biosimilars one year after they had become available in the European Union.METHODS: A 14-question anonymous survey was posted on the ECCO website. Members voluntarily responded in response to ECCO office invitations to participate in their surveys. Information on gender, job position, country, and experience with biologics also were collected.RESULTS: Out of the 118 responders, only 17% of responders had no access to biosimilars. Most responders regarded cost-sparing [92.4%] as the main advantage of biosimilars, considered immunogenicity [69%] to be their main concern, and estimated that post-marketing pharmacovigilance, well-designed randomized clinical trials and further studies of risk profile were needed [30.5%, 27%, 32.2%, respectively, a 30-40% reduction since 2013]. Only 35% of physicians think biosimilars should carry distinct International Nonproprietary Names, as compared with 66% in 2013, and 89.8% disagreed with automatic substitution of the originator with a biosimilar by a pharmacist. The originator and biosimilar were considered interchangeable by 44.4% of responders, as compared with 6% in 2013. Only 32.2% were against the extrapolation across indications, and only 25% would not extrapolate data across IBD. Finally, only 19.5% felt little or no confidence in the use of biosimilars, as compared with 63% in 2013.CONCLUSION: IBD specialists are generally well informed and educated about biosimilars. Compared with in 2013, there are now fewer concerns and more confidence about their use in clinical practice.

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SP - 1362

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JO - Journal of Crohn's and Colitis

JF - Journal of Crohn's and Colitis

SN - 1873-9946

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