Perspective

Equivalence of generic medicines in general and immunosuppressants in particular – a regulatory opinion on switching of ciclosporin, tacrolimus and mycophenolate mofetil

Published in: Volume 2 / Year 2013 / Issue 2
Author(s): , ,
Page: 86-90

Abstract: This position paper deals with our regulatory opinion on registered generic immunosuppressants such as ciclosporin, tacrolimus and mycophenolate mofetil, and provides arguments why these medicines are considered equally safe… Read More »

Why bioequivalence and unconditional interchangeability of generic drugs are not the same

Published in: Volume 2 / Year 2013 / Issue 2
Author(s):
Page: 83-5

Abstract: The patents for a number of cornerstone immunosuppressive drugs used in the field of solid organ transplantation have expired. Generic formulations are now available and several professional societies and… Read More »

The future of biological therapy: a pathway forward for biosimilars

Published in: Volume 2 / Year 2013 / Issue 1
Author(s): ,
Page: 36-40

Author byline as per print journal: Richard O Dolinar, MD; Michael S Reilly Abstract  Biologicals are advanced prescription drugs to treat cancer, rheumatoid arthritis HIV/AIDS, multiple sclerosis and other debilitating diseases.… Read More »

Health professionals in the risk communication process on counterfeit medicines

Published in: Volume 1 / Year 2012 / Issue 3-4
Author(s):
Page: 135-7

Abstract:  Communication is a key component in the fight against counterfeit medicines affecting the lives of patients. Two types of risk communication should be distinguished: pro-active and reactive. Reactive communication… Read More »

Terminology for biosimilars–a confusing minefield

Published in: Volume 1 / Year 2012 / Issue 3-4
Author(s): ,
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

Published in: Volume 1 / Year 2012 / Issue 2
Author(s):
Page: 89-91

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

Published in: Volume 1 / Year 2012 / Issue 2
Author(s): ,
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

Published in: Volume 1 / Year 2012 / Issue 1
Author(s):
Page: 39-41

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

Published in: Volume 1 / Year 2012 / Issue 1
Author(s):
Page: 34-8

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 »

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