Perspective
Terminology for biosimilars–a confusing minefield
Author(s): Meenu Wadhwa, PhD, Robin Thorpe, PhD, FRCPath
Page: 132-4
Author byline as per print journal: Robin Thorpe, PhD, FRCPath; Meenu Wadhwa, PhD Abstract: Biosimilars are firmly established in the EU as copy biologicals with a clear and effective regulatory route for… Read More »
Generic clopidogrel–the medicines agency’s perspective
Abstract: A number of generic products containing clopidogrel as the active substance have been marketed in Austria and the EU for some time. Due to different clopidogrel salt preparations and different indications, doubts… Read More »
Promoting access to biosimilars: a public−private partnership model for biosimilar development in underserved populations
Author(s): 1 Timothy Ken Mackey, MAS, Professor Bryan A Liang, MD, JD, PhD
Page: 84-8
Author byline as per print journal: Timothy Ken Mackey1,2, MAS; Professor Bryan A Liang1,3,4, MD, JD, PhD Abstract: Biologicals represent the future of pharmaceutical treatments and innovation. Yet, emerging and developing… Read More »
Generic and therapeutic orphans
Abstract: This commentary discusses the need to develop methods to ensure the availability of non-profitable, off-patent medicines to children and other populations. The history and some of the shortcomings of… Read More »
Myths, questions, facts about generic drugs in the EU
Abstract: Many generic drugs are now being prescribed and the trend is increasing. For example, in Austria, the number of all generics prescriptions has more than doubled from 11% in… Read More »
US interchangeability designation: are we ready to cut the Gordian knot?
Author byline as per print journal: Joseph P Park1, PhD; Gillian R Woollett2, MA, DPhil Abstract: US Food and Drug Administration’s (FDA) current thinking on interchangeability has evolved since the… Read More »
The challenge for drug shortage: lessons learned from the quality issues of Japanese generic drug companies
Author byline as per print journal: Takanao Hashimoto1, PhD; Akihiko Ozaki2, MD, PhD; Hiroaki Saito3, MD; Erika Yamashita4, Tetsuya Tanimoto5, MD; Mihajlo Jakovljevic6,7,8, MD, PhD Abstract: This paper examines the… Read More »