Abstract:
PURPOSE OF REVIEW:The goal is to review the most recent literature about biosimilars in inflammatory bowel disease (IBD), with emphasis on controversial regulatory issues. RECENT FINDINGS:Although biosimilars have been in use in Europe since 2005, the recent approval of CT-P13 (Remsima, Inflectra), a biosimilar of the reference infliximab (Remicade), by the European Medicines Agency (EMA) and several regulatory agencies has become a widely discussed topic in IBD, rheumatology, and other areas. Biologics are the main drivers of cost in current IBD units, and biosimilars can reduce prices thus increasing the availability of this type of treatment. The guidelines for evaluation of biosimilars are considerably different from those of the reference biologics, regulatory agencies relying on detailed in-vitro studies for defining 'high similarity', and requiring many fewer clinical data. 'High similarity' is considered sufficient for clinical trials, as the new molecule is demonstrated so structurally similar to the reference one that no significant difference in efficacy or safety is expected. Two trials in ankylosing spondylitis and rheumatoid arthritis gave no evidence of real difference and provided the required pharmacokinetic and PD data. The main controversy remains in the 'extrapolation' of indications, accepted by EMA but not by Health Canada. Position statements from several scientific societies and some expert's reviews have expressed concerns to the concept of extrapolation without direct IBD clinical evidence, whereas EMA experts have published detailed reviews supporting extrapolation. SUMMARY:Biosimilars in IBD are here to stay. New data are awaited to settle the controversy of extrapolation, but only the complex behavior of markets will show whether biosimilars fuel competition and extend access to biologics with significant cuts in drug costs.
journal_name
Curr Opin Gastroenteroljournal_title
Current opinion in gastroenterologyauthors
Gomollón Fdoi
10.1097/MOG.0000000000000184subject
Has Abstractpub_date
2015-07-01 00:00:00pages
290-5issue
4eissn
0267-1379issn
1531-7056pii
00001574-201507000-00004journal_volume
31pub_type
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journal_title:Current opinion in gastroenterology
pub_type: 杂志文章,评审
doi:10.1097/MOG.0b013e32829fb39f
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journal_title:Current opinion in gastroenterology
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journal_title:Current opinion in gastroenterology
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doi:10.1097/MOG.0b013e32832b36eb
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journal_title:Current opinion in gastroenterology
pub_type: 杂志文章,评审
doi:10.1097/MOG.0000000000000078
更新日期:2014-07-01 00:00:00
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journal_title:Current opinion in gastroenterology
pub_type: 杂志文章,评审
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更新日期:2006-03-01 00:00:00
abstract::Highlighting this year was the National Institutes of Health (NIH) State-of-the-Science Conference on endoscopic retrograde cholangiopancreatography. The panel addressed controversies in biliary endoscopy and set the framework for future funding for clinical research endeavors. With respect to biliary endoscopy, the l...
journal_title:Current opinion in gastroenterology
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doi:10.1097/00001574-200305000-00013
更新日期:2003-05-01 00:00:00
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journal_title:Current opinion in gastroenterology
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doi:10.1097/MOG.0b013e328336528d
更新日期:2010-03-01 00:00:00
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journal_title:Current opinion in gastroenterology
pub_type: 杂志文章,评审
doi:10.1097/MOG.0b013e328354cc36
更新日期:2012-07-01 00:00:00
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journal_title:Current opinion in gastroenterology
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更新日期:2007-07-01 00:00:00
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journal_title:Current opinion in gastroenterology
pub_type: 杂志文章,评审
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更新日期:2018-05-01 00:00:00
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journal_title:Current opinion in gastroenterology
pub_type: 杂志文章
doi:10.1097/00001574-200011000-00009
更新日期:2000-11-01 00:00:00
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journal_title:Current opinion in gastroenterology
pub_type: 杂志文章,评审
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更新日期:2013-01-01 00:00:00
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journal_title:Current opinion in gastroenterology
pub_type: 杂志文章,评审
doi:10.1097/MOG.0b013e32831ef1cd
更新日期:2009-03-01 00:00:00
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journal_title:Current opinion in gastroenterology
pub_type: 杂志文章,评审
doi:10.1097/MOG.0b013e32834ddab9
更新日期:2012-01-01 00:00:00
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journal_title:Current opinion in gastroenterology
pub_type: 杂志文章,评审
doi:10.1097/MOG.0000000000000455
更新日期:2018-09-01 00:00:00
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journal_title:Current opinion in gastroenterology
pub_type: 杂志文章
doi:10.1097/00001574-200003000-00006
更新日期:2000-03-01 00:00:00
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journal_title:Current opinion in gastroenterology
pub_type: 杂志文章,评审
doi:10.1097/MOG.0000000000000050
更新日期:2014-05-01 00:00:00
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journal_title:Current opinion in gastroenterology
pub_type: 杂志文章,评审
doi:10.1097/MOG.0b013e3282ff8b1f
更新日期:2008-07-01 00:00:00
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journal_title:Current opinion in gastroenterology
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更新日期:1999-03-01 00:00:00
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journal_title:Current opinion in gastroenterology
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更新日期:2014-09-01 00:00:00
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journal_title:Current opinion in gastroenterology
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journal_title:Current opinion in gastroenterology
pub_type: 杂志文章,评审
doi:10.1097/01.mog.0000239863.96833.c0
更新日期:2006-09-01 00:00:00
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journal_title:Current opinion in gastroenterology
pub_type: 杂志文章
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更新日期:1999-03-01 00:00:00
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journal_title:Current opinion in gastroenterology
pub_type: 杂志文章,评审
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更新日期:2015-09-01 00:00:00
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journal_title:Current opinion in gastroenterology
pub_type: 杂志文章,评审
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更新日期:2016-05-01 00:00:00
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journal_title:Current opinion in gastroenterology
pub_type: 杂志文章,评审
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更新日期:2008-09-01 00:00:00
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pub_type: 杂志文章,评审
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更新日期:2005-09-01 00:00:00
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journal_title:Current opinion in gastroenterology
pub_type: 杂志文章,评审
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更新日期:2009-01-01 00:00:00
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journal_title:Current opinion in gastroenterology
pub_type: 杂志文章,评审
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更新日期:2010-03-01 00:00:00
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journal_title:Current opinion in gastroenterology
pub_type: 杂志文章
doi:10.1097/00001574-200111000-00005
更新日期:2001-11-01 00:00:00