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Biosimilars: the science of extrapolation

Martina Weise, Pekka Kurki, Elena Wolff-Holz, Marie-Christine Bielsky and Christian K. Schneider

Abstract

Despite the establishment of a specific approval pathway, the issuance of detailed scientific guidelines for the development of similar biological medicinal products (so-called 'biosimilars') and the approval of several biosimilars in the European Union, acceptance of biosimilars in the medical community continues to be low. This is especially true in therapeutic indications for which no specific clinical trials with the biosimilar have been performed and which have been licensed based on extrapolation of efficacy and safety data from other indications. This article addresses the concerns frequently raised in the medical community about the use of biosimilars in such 'extrapolated' indications, and explains the underlying scientific and regulatory decision making including some real-life examples from recently licensed biosimilars.

  • Submitted June 30, 2014.
  • Accepted September 25, 2014.