Review Article
Published in:
Volume 3 / Year 2014 / Issue 2
Volume 3 / Year 2014 / Issue 2
Interchangeability. An insurmountable fifth hurdle?
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): Bodo Haas, PhD, Christoph Unkrig, MD, Frauke Naumann-Winter, PhD, Harald Enzmann, MD, Henrike Potthast, PhD, Lea Röper, BSc, Niels Eckstein, PhD, Ulrike Hermes, PhD
Page: 79-87
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
Author(s): J Michael Nicholas, PhD
Page: 71-8
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 »