Evaluating imbalances of adverse events during biosimilar development

Biosimilars are designed to be highly similar to approved or licensed (reference) biologics and are evaluated based on the totality of evidence from extensive analytical, nonclinical and clinical studies. As part of the stepwise approach recommended by regulatory agencies, the first step in the clin...

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Bibliographic Details
Published in:mAbs 2016-07, Vol.8 (5), p.861-866
Main Authors: Vana, Alicia M., Freyman, Amy W., Reich, Steven D., Yin, Donghua, Li, Ruifeng, Anderson, Scott, Jacobs, Ira A., Zacharchuk, Charles M., Ewesuedo, Reginald
Format: Article
Language:English
Subjects:
Antibodies, Monoclonal, Humanized - adverse effects
Biosimilar
Biosimilar Pharmaceuticals - adverse effects
breast cancer
Brief Report
Clinical Trials, Phase I as Topic
Double-Blind Method
Drug Approval
HER2
Humans
Randomized Controlled Trials as Topic
safety
trastuzumab
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Summary:Biosimilars are designed to be highly similar to approved or licensed (reference) biologics and are evaluated based on the totality of evidence from extensive analytical, nonclinical and clinical studies. As part of the stepwise approach recommended by regulatory agencies, the first step in the clinical evaluation of biosimilarity is to conduct a pharmacokinetics similarity study in which the potential biosimilar is compared with the reference product. In the context of biosimilar development, a pharmacokinetics similarity study is not necessarily designed for a comparative assessment of safety. Development of PF-05280014, a potential biosimilar to trastuzumab, illustrates how a numerical imbalance in an adverse event in a small pharmacokinetics study can raise questions on safety that may require additional clinical trials.
ISSN:1942-0862
1942-0870
DOI:10.1080/19420862.2016.1171431