Clinical trials required by European regulators to compare biosimilar products with corresponding biologic brands are surplus to requirements and may even be a barrier for the development of biosimilars of more complicated biologics, state Professor Huub Schellekens and Dr Ellen Moors of Utrecht University, The Netherlands, in a Nature Biotechnology Commentary of January 2010. “If you look in detail at the accepted and rejected biosimilars and the differences, then you might conclude that proof of clinical equivalence is actually overdue,” comments Professor Arnold Vulto of the Erasmus MC, Rotterdam.
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Biosimilars
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