Review Article
Assessment of the interchangeability between generics
Author(s): Alfredo García Arieta, PhD, Henrike Potthast, PhD, Hubert Leufkens, PhD, Jan Welink, John Gordon, PhD, Luther Gwaza, BPharm, MPhil, Marc Maliepaard, PhD, Matthias Stahl, MD
Page: 55-9
Author byline as per print journal: Luther Gwaza1,2, BPharm, MPhil; John Gordon3, PhD; Henrike Potthast4, PhD; Marc Maliepaard5, PhD; Jan Welink5, Hubert Leufkens1,5, PhD; Matthias Stahl6, MD; Alfredo García-Arieta7, PhD… Read More »
Life begins at forty – hybridomas: ageing technology holds promise for future drug discoveries
Abstract: Hybridomas were developed in 1975 as a stable platform for creating monoclonal antibodies (mAbs). Over the past 40 years, hybridomas have been a leading platform for creating mAbs, yet… Read More »
Biosimilars: extrapolation of clinical use to other indications
Author(s): 1 Theresa L Gerrard, PhD, 2 Gordon Johnston, RPh, MS, David R Gaugh, RPh
Page: 118-24
Abstract: Biosimilars should be approved for all the clinical indications of the reference product based on the totality of the evidence even if there is no clinical safety and efficacy… Read More »
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, Associate Professor Valderilio Feijó Azevedo, MD, PhD, MSc, Eduardo Mysler, MD, Eva Maria Ruiz de Castilla, MS, MAA, PhD, Francisco Javier Flores-Murrieta, PhD, FCP, Juana Hughes, MSc
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 »