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

• Published in: BioDrugs : clinical immunotherapeutics, biopharmaceuticals, and gene therapy Vol. 30; no. 6; pp. 489 - 523
• Main Authors: Jacobs, Ira, Petersel, Danielle, Shane, Lesley G., Ng, Chee-Keng, Kirchhoff, Carol, Finch, Gregory, Lula, Sadiq
• Format: Journal Article
• Language: English
• Published: Cham Springer International Publishing 01.12.2016; Springer Nature B.V
• Subjects: Antibodies; Antibodies, Monoclonal - therapeutic use; Arthritis; Biological products; Biomedical and Life Sciences; Biomedicine; Biosimilar Pharmaceuticals - therapeutic use; Cancer Research; Chronic Disease; Cost control; Crohn's disease; FDA approval; Humans; Inflammation - drug therapy; Inflammatory bowel disease; Labeling; Literature reviews; Molecular Medicine; Neoplasms - drug therapy; Pharmaceutical industry; Pharmacotherapy; Proteins; Psoriasis; Recombinant Fusion Proteins - therapeutic use; Rituximab - therapeutic use; Serial Publications - statistics & numerical data; Serial Publications - trends; Studies; Systematic Review; United States > US; South Korea; Abciximab; Infliximab; Etanercept; Adalimumab; Ranibizumab
• ISSN: 1173-8804; 1179-190X; 1179-190X
• DOI: 10.1007/s40259-016-0199-9

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.