Biosimilars for the Treatment of Chronic Inflammat

Authors: Ira Jacobs Danielle Petersel Leah Isakov Sadiq Lula K Lea Sewell

Publish Date: 2016/11/25

Volume: 30, Issue: 6, Pages: 525-570

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Abstract

The objective of this study was to systematically collate all published data in order to assess the weight quantity and quality of available evidence for each molecule and inform and support healthcare decisionmaking in chronic inflammatory diseasesMEDLINE® EMBASE® and ISI Web of Science® were searched to September 2015 Selected conference proceedings were searched from 2012 to July 2015 Studies disclosing biosimilars with unique identifiers were categorized by originator study type and indication Risk of bias assessments were performed Intended copies were differentiated as commercially available agents without evidence of rigorous comparative biosimilarity evaluationsProposed biosimilars for adalimumab etanercept infliximab and rituximab are reported in the published literature Across indications approved biosimilars infliximab CTP13 SB2 and etanercept SB4 have published studies involving the largest number of patients or healthy subjects n = 1405 743 and 734 respectively mostly in rheumatoid arthritis At data cutoff only CTP13 had published data in ankylosing spondylitis n = 250 randomized control trial and ulcerative colitis/Crohn’s disease n = 336 observational studies Published data were not available for ongoing studies in psoriasis patients Four intended copies were identified in published studies total n = 1430 n = 1372 in observational studies Thematic analysis of nonempirical publications showed that indication extrapolation remains an issue particularly for gastroenterologistsWhile most agents display a moderate to high degree of similarity to their originator in the published studies identified large discrepancies persist in the overall amount and type of data available in the public domain Significant gaps exist particularly for intended copies reinforcing the need to maintain a clear differentiation between these molecules and true biosimilarsThere is a significant body of evidence in the published literature to support infliximab biosimilars CTP13 SB2 and etanercept biosimilar SB4 for rheumatoid arthritis but knowledge gaps still exist both in the amount and type of data available These gaps are more pronounced for other molecules across chronic inflammatory diseases and most pronounced for intended copies

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