Review Article

Biosimilars patent litigation in the EU and the US: a comparative strategic overview

Published in: Volume 4 / Year 2015 / Issue 3
Page: 113-7

Abstract: Biosimilars are highly similar versions of reference biological products, some with the potential to be deemed ‘interchangeable’ by regulatory bodies, such as the US Food and Drug Administration. Biosimilar… Read More »

Generic pregabalin; current situation and implications for health authorities, generics and biosimilars manufacturers in the future

Published in: Volume 4 / Year 2015 / Issue 3
Author(s): ,
Page: 125-35

Author byline as per print journal: Brian Godman, BSc, PhD; Michael Wilcock, MPharm; Andrew Martin, MPharm; Scott Bryson, MSc, MPH; Christoph Baumgärtel, MD; Tomasz Bochenek, MD, MPH, PhD; Winne de Bruyn, BSc;… Read More »

The refinement of the super generic concept: semantic challenge for product re-innovation?

Published in: Volume 4 / Year 2015 / Issue 1
Author(s): ,
Page: 25-32

Background: Uptake of super generic or hybrid pharmaceuticals has decelerated despite their important economic potential for the generic pharmaceutical industry. The aim of switching to these product portfolios was to… Read More »

Safety assessment of biosimilars in Europe: a regulatory perspective

Published in: Volume 3 / Year 2014 / Issue 4
Author(s): ,
Page: 180-3

Abstract: Clinical safety is important during the development of a biosimilar. This paper provides an overview of the main aspects related to the safety assessment of biosimilars. The European Medicines… Read More »

Recommendations for the regulation of biosimilars and their implementation in Latin America

Published in: Volume 3 / Year 2014 / Issue 3
Author(s): , , , , ,
Page: 143-8

Author byline as per print journal: Valderilio Feijó Azevedo, MD, PhD; Eduardo Mysler, MD; Alexis Aceituno Álvarez, PharmD, PhD; Juana Hughes, MSc; Francisco Javier Flores-Murrieta, PhD, FCP; Eva Maria Ruiz de Castilla, MS, MAA, PhD… Read More »

Interchangeability. An insurmountable fifth hurdle?

Published in: Volume 3 / Year 2014 / Issue 2
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

Published in: Volume 3 / Year 2014 / Issue 2
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

Published in: Volume 3 / Year 2014 / Issue 2
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 »

Statistical considerations for the development of biosimilar products

Published in: Volume 3 / Year 2014 / Issue 1
Author(s): ,
Page: 21-5

Abstract: As the patents of a growing number of biological medicines have already expired or are due to expire, it has led to an increased interest from both the biopharmaceutical… Read More »

Immunogenicity of biosimilar monoclonal antibodies

Published in: Volume 2 / Year 2013 / Issue 4
Page: 188-93.

Abstract: Biosimilar monoclonal antibodies (mAbs) are making their way onto the drug market. Because these are complex molecules in terms of structure and function, assessing similarity between originator and biosimilar… Read More »

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