Dataset Information

Biosimilars for the Treatment of Chronic Inflammatory Diseases: A Systematic Review of Published Evidence.

ABSTRACT:

Background

Clinicians are required to assimilate, critically evaluate, and extrapolate information to support appropriate use of biosimilars across indications.

Objectives

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 decision-making in chronic inflammatory diseases.

Methods

MEDLINE^®, 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 evaluations.

Results

Proposed biosimilars for adalimumab, etanercept, infliximab, and rituximab are reported in the published literature. Across indications, approved biosimilars infliximab CT-P13, 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 cut-off, only CT-P13 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 non-empirical publications showed that indication extrapolation remains an issue, particularly for gastroenterologists.

Conclusions

While 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 biosimilars.

SUBMITTER: Jacobs I

PROVIDER: S-EPMC5126192 | biostudies-literature | 2016 Dec

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Biosimilars for the Treatment of Chronic Inflammatory Diseases: A Systematic Review of Published Evidence.

Jacobs Ira I Petersel Danielle D Isakov Leah L Lula Sadiq S Lea Sewell K K

BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy 20161201 6

<h4>Background</h4>Clinicians are required to assimilate, critically evaluate, and extrapolate information to support appropriate use of biosimilars across indications.<h4>Objectives</h4>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 decision-making in chronic inflammatory diseases.<h4>Methods</h4>MEDLINE<sup>®</sup>, EMBASE<sup>®</sup>, and ...[more]

PMID: 27885553

Similar Datasets

Project description:BackgroundBiologic treatments for cancer continue to place a significant economic burden on healthcare stakeholders. Biosimilar therapies may help reduce this burden through cost savings, thereby increasing patient access.ObjectivesThe purpose of this study was to collate all published data to assess the weight of available evidence (quantity and quality) for proposed monoclonal antibody biosimilars and intended copies, for the treatment of cancer.MethodsMEDLINE®, Embase®, and ISI Web of Science® databases were searched to September 2015. Conference proceedings (17) were searched (2012 to July 2015). Searches of the United States National Library of Medicine ClinicalTrials.gov registry were also conducted. Risk of bias assessments were undertaken to assess data strength and validity.ResultsProposed biosimilars were identified in 23 studies (36 publications) in oncology and ten studies in 14 publications in oncology and chronic inflammatory diseases for bevacizumab, rituximab, and trastuzumab originators. Based on our review of the included published studies, and as inferred from the conclusions of study authors, the identified proposed biosimilars exhibit close similarity to their originators. Published data were also retrieved on intended copies of rituximab. It remains unclear what role these agents may have, as publications on rigorous clinical studies are lacking for these molecules.ConclusionWhile biosimilar products have the potential to improve patient access to important biologic therapies, robust evidence of outcomes for monoclonal antibody biosimilars in treating cancer patients, including data from comparative efficacy and safety trials, is not yet available in the published literature. Significant data gaps exist, particularly for intended copies, which reinforces the need to maintain a clear differentiation between these molecules and true biosimilars. As more biosimilars become available for use, it will be important for stakeholders to understand fully the robustness of overall evidence used to demonstrate biosimilarity and gain regulatory approval.

Dataset Information

Biosimilars for the Treatment of Chronic Inflammatory Diseases: A Systematic Review of Published Evidence.

Background

Objectives

Methods

Results

Conclusions

Publications

Biosimilars for the Treatment of Chronic Inflammatory Diseases: A Systematic Review of Published Evidence.

Similar Datasets

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