Dataset Information

Monoclonal Antibody and Fusion Protein Biosimilars Across Therapeutic Areas: A Systematic Review of Published Evidence.

ABSTRACT:

Background

Despite regulatory efforts to formalize guidance policies on biosimilars, there remains a need to educate healthcare stakeholders on the acknowledged definition of biosimilarity and the data that underpin it.

Objectives

The objectives of the study were to systematically collate published data for monoclonal antibodies and fusion protein biosimilars indicated for cancer, chronic inflammatory diseases, and other indications, and to explore differences in the type and weight (quantity and quality) of available evidence.

Methods

MEDLINE, Embase, and ISI Web of Science were searched to September 2015. Conference proceedings (n = 17) were searched 2012 to July 2015. Included studies were categorized by originator, study type, and indication. To assess data strength and validity, risk of bias assessments were undertaken.

Results

Across therapeutic areas, 43 named (marketed or proposed) biosimilars were identified for adalimumab, abciximab, bevacizumab, etanercept, infliximab, omalizumab, ranibizumab, rituximab, and trastuzumab originators. Infliximab CT-P13, SB2, and etanercept SB4 biosimilars have the greatest amount of published evidence of similarity with their originators, based on results of clinical studies involving larger numbers of patients or healthy subjects (N = 1405, 743, and 734, respectively). Published data were also retrieved for marketed intended copies of etanercept and rituximab.

Conclusions

This unbiased synthesis of the literature exposed significant differences in the extent of published evidence between molecules at preclinical, clinical, and post-marketing stages of development, providing clinicians and payers with a consolidated view of the available data and remaining gaps.

SUBMITTER: Jacobs I

PROVIDER: S-EPMC5126212 | biostudies-literature | 2016 Dec

REPOSITORIES: biostudies-literature

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Publications

Monoclonal Antibody and Fusion Protein Biosimilars Across Therapeutic Areas: A Systematic Review of Published Evidence.

Jacobs Ira I Petersel Danielle D Shane Lesley G LG Ng Chee-Keng CK Kirchhoff Carol C Finch Gregory G Lula Sadiq S

BioDrugs : clinical immunotherapeutics, biopharmaceuticals and gene therapy 20161201 6

<h4>Background</h4>Despite regulatory efforts to formalize guidance policies on biosimilars, there remains a need to educate healthcare stakeholders on the acknowledged definition of biosimilarity and the data that underpin it.<h4>Objectives</h4>The objectives of the study were to systematically collate published data for monoclonal antibodies and fusion protein biosimilars indicated for cancer, chronic inflammatory diseases, and other indications, and to explore differences in the type and weig ...[more]

PMID: 27807766

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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.

Project description:BackgroundClinicians are required to assimilate, critically evaluate, and extrapolate information to support appropriate use of biosimilars across indications.ObjectivesThe 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.MethodsMEDLINE®, 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.ResultsProposed 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.ConclusionsWhile 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.

Project description:Study Design?Systematic review. Clinical Questions?(1) Has the proportion and number of randomized controlled trials (RCTs) as an indicator of quality of evidence regarding lumbar fusion increased over the past 10 years? (2) Is there a difference in the proportion of RCTs among the four primary fusion diagnoses (degenerative disk disease, spondylolisthesis, deformity, and adjacent segment disease) over the past 10 years? (3) Is there a difference in the type and quality of clinical outcomes measures reported among RCTs over time? (4) Is there a difference in the type and quality of adverse events measures reported among RCTs over time? (5) Are there changes in fusion surgical approach and techniques over time by diagnosis over the past 10 years? Methods?Electronic databases and reference lists of key articles were searched from January 1, 2004, through December 31, 2013, to identify lumbar fusion RCTs. Fusion studies designed specifically to evaluate recombinant human bone morphogenetic protein-2 or other bone substitutes, revision surgery studies, nonrandomized comparison studies, case reports, case series, and cost-effectiveness studies were excluded. Results?Forty-two RCTs between January 1, 2004, and December 31, 2013, met the inclusion criteria and form the basis for this report. There were 35 RCTs identified evaluating patients diagnosed with degenerative disk disease, 4 RCTs evaluating patients diagnosed with degenerative spondylolisthesis, and 3 RCTs evaluating patients with a combination of degenerative disk disease and degenerative spondylolisthesis. No RCTs were identified evaluating patients with deformity or adjacent segment disease. Conclusions?This structured review demonstrates that there has been an increase in the available clinical database of RCTs using patient-reported outcomes evaluating the benefit of lumbar spinal fusion for the diagnoses of degenerative disk disease and degenerative spondylolisthesis. Gaps remain in the standardization of reportage of adverse events in such trials, as well as uniformity of surgical approaches used. Finally, continued efforts to develop higher-quality data for other surgical indications for lumbar fusion, most notably in the presence of adult spinal deformity and revision of prior surgical fusions, appear warranted.

Dataset Information

Monoclonal Antibody and Fusion Protein Biosimilars Across Therapeutic Areas: A Systematic Review of Published Evidence.

Background

Objectives

Methods

Results

Conclusions

Publications

Monoclonal Antibody and Fusion Protein Biosimilars Across Therapeutic Areas: A Systematic Review of Published Evidence.

Similar Datasets

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