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BioDrugs. 2016 Dec;30(6):489-523.

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

Author information

Global Established Pharma Medicines Development Group, Pfizer Inc., 235 East 42nd Street, New York, NY, 10017-5755, USA.
Global Established Pharma Medicines Development Group, Pfizer Inc., 235 East 42nd Street, New York, NY, 10017-5755, USA.
Outcomes and Evidence, Global Health and Value, Pfizer Inc., New York, NY, USA.
Analytical Research and Development, Biotherapeutics Pharmaceutical Sciences, Pfizer Inc., Andover, MA, USA.
Global Technology Services, Biotechnology and Aseptic Sciences, Pfizer Inc., Chesterfield, MO, USA.
Drug Safety Research and Development, Pfizer Inc., Groton, CT, USA.
Envision Pharma Group, London, UK.



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.


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.


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.


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.


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.

[Indexed for MEDLINE]
Free PMC Article

Conflict of interest statement

Compliance with Ethical Standards Author Contributions All authors were involved in drafting the article and revising it critically for important intellectual content. All authors read and approved the final manuscript submitted for publication. Conflict of interest IJ, DP, CKN, CK, and LS are full-time employees and shareholders of Pfizer Inc. GF was a full-time employee of Pfizer Inc. at the time the study was conducted. SL is a full-time employee of Envision Pharma Group who were paid consultants to Pfizer in connection with the development of the SLR report that forms the basis of this manuscript. He was not compensated for his role in the development of this manuscript. Funding The SLR to support this manuscript was sponsored by Pfizer Inc.

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