Review Article
Biosimilars patent litigation in the EU and the US: a comparative strategic overview
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
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 »
Safety assessment of biosimilars in Europe: a regulatory perspective
Author(s): Christian K Schneider, MD, Thijs J Giezen, PharmD, PhD, MSc
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
Author(s): Alexis Aceituno Álvarez, PharmD, PhD, Eduardo Mysler, MD, Eva Maria Ruiz de Castilla, MS, MAA, PhD, Francisco Javier Flores-Murrieta, PhD, FCP, Juana Hughes, MSc, Valderilio Feijó Azevedo, MD, PhD, MBA
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?
Author(s): Hans C Ebbers, PhD, Paul Chamberlain, BSc
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): 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
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
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
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
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 »