The immunogenicity of biosimilar infliximab: can we extrapolate the data across indications?

4.00
Hdl Handle:
http://hdl.handle.net/11287/593977
Title:
The immunogenicity of biosimilar infliximab: can we extrapolate the data across indications?
Authors:
Ben-Horin, S.; Heap, Graham A.; Ahmad, Tariq; Kim, H.; Kwon, T.; Chowers, Y.
Abstract:
Biopharmaceuticals or 'biologics' have revolutionized the treatment of many diseases. However, some patients generate an immune response to such drugs, potentially limiting clinical efficacy and safety. Infliximab (Remicade((R))) is a monoclonal antibody used to treat several immune-mediated inflammatory disorders. A biosimilar of infliximab, CT-P13 (Remsima((R)), Inflectra((R))), has recently been approved in Europe for all indications in which infliximab is approved. Approval of CT-P13 was based in part on extrapolation of clinical trial data from two indications (rheumatoid arthritis and ankylosing spondylitis) to all other indications, including inflammatory bowel disease. This review discusses the validity of extrapolating immunogenicity data across indications - a process adopted by the EMA as part of their biosimilar approval process - with a focus on CT-P13.
Citation:
Expert Rev Gastroenterol Hepatol. 2015 Sep;9 Suppl 1:27-34
Publisher:
Taylor & Francis
Journal:
Expert review of gastroenterology & hepatology
Issue Date:
22-Sep-2015
URI:
http://hdl.handle.net/11287/593977
DOI:
10.1586/17474124.2015.1091307
PubMed ID:
26395532
Additional Links:
http://www.tandfonline.com/doi/full/10.1586/17474124.2015.1091307
Type:
Journal Article
Language:
eng
ISSN:
1747-4132
Appears in Collections:
2015 RD&E publications; Gastroenterology

Full metadata record

DC FieldValue Language
dc.contributor.authorBen-Horin, S.en
dc.contributor.authorHeap, Graham A.en
dc.contributor.authorAhmad, Tariqen
dc.contributor.authorKim, H.en
dc.contributor.authorKwon, T.en
dc.contributor.authorChowers, Y.en
dc.date.accessioned2016-01-19T12:38:11Zen
dc.date.available2016-01-19T12:38:11Zen
dc.date.issued2015-09-22en
dc.identifier.citationExpert Rev Gastroenterol Hepatol. 2015 Sep;9 Suppl 1:27-34en
dc.identifier.issn1747-4132en
dc.identifier.pmid26395532en
dc.identifier.doi10.1586/17474124.2015.1091307en
dc.identifier.urihttp://hdl.handle.net/11287/593977en
dc.description.abstractBiopharmaceuticals or 'biologics' have revolutionized the treatment of many diseases. However, some patients generate an immune response to such drugs, potentially limiting clinical efficacy and safety. Infliximab (Remicade((R))) is a monoclonal antibody used to treat several immune-mediated inflammatory disorders. A biosimilar of infliximab, CT-P13 (Remsima((R)), Inflectra((R))), has recently been approved in Europe for all indications in which infliximab is approved. Approval of CT-P13 was based in part on extrapolation of clinical trial data from two indications (rheumatoid arthritis and ankylosing spondylitis) to all other indications, including inflammatory bowel disease. This review discusses the validity of extrapolating immunogenicity data across indications - a process adopted by the EMA as part of their biosimilar approval process - with a focus on CT-P13.en
dc.language.isoengen
dc.publisherTaylor & Francisen
dc.relation.urlhttp://www.tandfonline.com/doi/full/10.1586/17474124.2015.1091307en
dc.titleThe immunogenicity of biosimilar infliximab: can we extrapolate the data across indications?en
dc.typeJournal Articleen
dc.identifier.journalExpert review of gastroenterology & hepatologyen

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