Review Article

Published in:
Volume 3 / Year 2014 / Issue 2

Interchangeability. An insurmountable fifth hurdle?

Author(s): ,
Page: 88-93

Abstract: The arrival of biosimilars has led to considerable debate on how they can be used in clinical practice. A particular concern is related to the question of whether a… Read More »

Tyrosine kinase inhibitors becoming generic drugs – risks and chances from a regulatory perspective

Author(s): , , , , , , ,
Page: 79-87

Author byline as per print journal: Niels Eckstein, PhD; Lea Röper, BSc; Bodo Haas, PhD; Henrike Potthast, PhD; Ulrike Hermes, PhD; Christoph Unkrig, MD; Frauke Naumann-Winter, PhD; Harald Enzmann, MD Aim: To provide a systematic overview on: i)… Read More »

Clinical development, immunogenicity, and interchangeability of follow-on complex drugs

Page: 71-8

Abstract: Although not derived from living sources, non-biological complex drug (NBCD) products have the immunogenicity and molecular complexity of biological drugs. NBCDs typically contain heterogenous mixtures of closely related nanoparticulate… Read More »

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