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Measures of #biosimilarity in monoclonal antibodies in oncology: case of bevacizumab #mAbs #biosimilars #biosimilar
http://t.co/EmMApVxrEy
Highlights
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Challenges remain in establishing biosimilarity of anticancer agents.
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Preclinical studies can be sensitive but can lack clinical relevance.
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It is not realistic to establish noninferiority of biosimilar bevacizumab using accepted clinical outcomes.
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Novel clinical endpoints may include adverse reactions or unauthorized indications.
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The authorization of biosimilars in oncology at realistic costs requires novel approaches.
Via Krishan Maggon
Drug Discovery Today
Volume 18, Issues 17–18, September 2013, Pages 872–879
Review Measures of biosimilarity in monoclonal antibodies in oncology: the case of bevacizumabHans C. Ebbers1, Peter J.K. van Meer3, Ellen H.M. Moors2, Aukje K. Mantel-Teeuwisse1, , , Hubert G.M. Leufkens1, Huub Schellekens2, 3Available online 18 May 2013 doi:10.1016/j.drudis.2013.05.004