Silvio Danese1,2, Gionata Fiorino3, Pierre Michetti4. 1. IBD Center, Humanitas Research Hospital, Rozzano, Milan, Italy sdanese@hotmail.com. 2. Department of Biomedical Sciences, Humanitas University, Rozzano, Milan, Italy. 3. IBD Center, Humanitas Research Hospital, Rozzano, Milan, Italy. 4. Gastro-entérologie La Source-Beaulieu, Lausanne, Switzerland.
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.
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.
Authors: Lisa J T Smits; Anna Grelack; Lauranne A A P Derikx; Dirk J de Jong; Aura A J van Esch; Ronald S Boshuizen; Joost P H Drenth; Frank Hoentjen Journal: Dig Dis Sci Date: 2017-06-30 Impact factor: 3.199
Authors: Tim A Kanters; Jelena Stevanovic; Isabelle Huys; Arnold G Vulto; Steven Simoens Journal: Front Pharmacol Date: 2017-05-31 Impact factor: 5.810