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Establishing a new marketplace for biologic therapy with biosimilar agents: importance of extrapolation of data

Authors Bressler B, Dingermann T

Received 12 December 2014

Accepted for publication 3 March 2015

Published 1 June 2015 Volume 2015:5 Pages 41—48


Checked for plagiarism Yes

Review by Single-blind

Peer reviewer comments 2

Editor who approved publication: Dr Ajay Singh

Brian Bressler,1 Theo Dingermann2

1St Paul’s Hospital, University of British Columbia, Vancouver, BC, Canada; 2Institute of Pharmaceutical Biology, Frankfurt, Germany

Abstract: Despite their enormous value for our health care system, biopharmaceuticals have become a serious threat to the system itself due to their high cost. Costs may be warranted if the medicine is new and innovative; however, it is no longer an innovation when its patent protection expires. As patents and exclusivities expire on biological drugs, biosimilar products defined as highly similar to reference biologics are being marketed. The goal of biosimilar development is to establish a high degree of biosimilarity, not to reestablish clinical efficacy and safety. Current sophisticated analytical methods allow the detection of even small changes in quality attributes and can therefore enable sensitive monitoring of the batch-to-batch consistency and variability of the manufacturing process. The European Medicines Agency (EMA), US Food and Drug Administration (FDA), and Health Canada have determined that a reduced number of nonclinical and clinical comparative studies can be sufficient for approval with clinical data from the most sensitive indication extrapolated to other indications. Extrapolation of data is a scientifically based principle, guided by specific criteria, and if approved by the EMA, FDA, and/or Health Canada is appropriate. Enablement of extrapolation of data is a core principle of biosimilar development, based on principles of comparability and necessary to fully realize cost savings for these drugs.

Keywords: biosimilars, Inflectra, infliximab, pharmacoeconomics, Canada, Europe

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