Perspective
Licensing and prescribing biosimilars in Australia
Author(s): Professor David A Power, MD, PhD, FRCP, FRACP
Page: 152-4
Abstract: Some years ago, Australian regulatory authorities decided to follow the path laid down by the European Medicines Agency in adopting a process for approval of biosimilars. This has been… Read More »
Biosimilarity in Latin America
Author(s): 1 Chang Chiann, PhD, 2 Leonardo de Souza Teixeira, PhD, 3 Fabiana Fernandes de Santana e Silva Cardoso, MSc, 4 Isabela da Costa César, PhD, 5 Gerson Antônio Pianetti, PhD
Page: 94-6
Abstract: The introduction of new legislation in Latin America for the approval of biosimilar products follows implementation of EU legislation in 2005 for biosimilars approval. The establishment of regulatory processes… Read More »
Biosimilars in oncology: current and future perspectives
Abstract: Cancer represents a significant, and growing, burden on healthcare systems. This is driven, at least in part, by escalating cancer drug budgets. Loss of patent protection on biopharmaceuticals enables… Read More »
Equivalence of generic medicines in general and immunosuppressants in particular – a regulatory opinion on switching of ciclosporin, tacrolimus and mycophenolate mofetil
Author(s): 2 Yang Yu, PharmD, 3 Professor Hubert GM Leufkens, PharmD, PhD, Marc Maliepaard, PhD
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
Author(s): Professor Teun van Gelder, MD, PhD
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
Author(s): 1 Richard O Dolinar, MD, Michael S Reilly, Esq
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
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
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 »