BioDrugs (01/13/2016) Vol. 30, No. 1, P. 1; Ebbers, H.C.; Chamberlain, Paul

Researchers from Utrecht University in the Netherlands and NDA Advisory Services in the United Kingdom discuss controversies in establishing biosimilarity. They note there is still significant discord over the scientific basis for extrapolation of indications for biosimilars. Related to extrapolation is the issue of communicating the evidence base for authorizing biosimilars to healthcare professionals. The authors also consider decisions by regulatory agencies worldwide regarding the authorization and labeling of biosimilar products.

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