Blood (11/20/14) Vol. 124, No. 22, P. 3191; Weise, M.; Kurki, P.; Wolff-Holz, E.

The medical community remains hesitant to accept biosimilars, researchers note. This occurs in spite of the establishment of a specific approval pathway, detailed scientific guidelines for the development of biosimilars, and the approval of several biosimilar drugs in the European Union. The lack of acceptance is particularly noticeable in therapeutic indications for which no specific clinical trials with the biosimilar have been performed and in which licensing is based on extrapolation of efficacy and safety data from other indications. Researchers have examined the concerns in the medical community about the use of biosimilars in extrapolated indications as well as the underlying scientific and regulatory decision-making.

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