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Biosimilars for the Treatment of Cancer: A Systematic Review of Published Evidence
Ira Jacobs1, Reginald Ewesuedo2, Sadiq Lula3
1Pfizer Inc, Pfizer Essential Health, 235 East 42nd Street, New York, NY, 10017-5755, USA. ira.jacobs@pfizer.com.
Background:
Biologic 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.
Objectives:
The 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.
Methods:
MEDLINE®, 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.
Results:
Proposed 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.
Conclusion:
While 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.
Insights
Biosimilar monoclonal antibodies show promise for cancer treatment access, but robust clinical data is limited. Further research is needed to confirm efficacy and safety, especially for intended copies.
Area of Science:
- Oncology
- Pharmacology
- Health Economics
Background:
- Biologic cancer treatments are costly, impacting healthcare systems and patient access.
- Biosimilar therapies offer potential cost savings and improved access to essential medications.
Purpose of the Study:
- To evaluate the evidence for monoclonal antibody biosimilars and intended copies used in cancer treatment.
- To assess the quantity and quality of published data on these therapeutic agents.
Main Methods:
- Comprehensive literature search of MEDLINE, Embase, and Web of Science databases up to September 2015.
- Searched conference proceedings (2012-2015) and ClinicalTrials.gov registry.
- Conducted risk of bias assessments to evaluate data strength and validity.
Main Results:
- Identified 23 studies (36 publications) on biosimilars for bevacizumab, rituximab, and trastuzumab in oncology.
- Published data suggest proposed biosimilars are similar to originators.
- Limited data exists for intended copies, with a lack of rigorous clinical studies.
Conclusions:
- Biosimilars may enhance patient access to biologic cancer therapies.
- Robust evidence, including comparative efficacy and safety trials, is not yet widely available for monoclonal antibody biosimilars in oncology.
- Significant data gaps persist, especially for intended copies, necessitating clear differentiation from true biosimilars.
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