GENERICS AND BIOSIMILARS INITIATIVE JOURNAL
Official Journal of the Generics and Biosimilars Initiative
Volume 2 / Year 2013 / Issue 2
Perspective
Equivalence of generic medicines in general and immunosuppressants in particular – a regulatory opinion on switching of ciclosporin, tacrolimus and mycophenolate mofetil
Author(s): Marc Maliepaard, PhD, Yang Yu, PharmD, Professor Hubert GM Leufkens, PharmD, PhD
Page: 86-90Abstract: 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 and effective as the branded drug based on demonstrated bioequivalence. Though regulators acknowledge the worries from the field, we are of the opinion that there […]
Biosimilarity in Latin America
Author(s): Chang Chiann, PhD, Leonardo de Souza Teixeira, PhD, Fabiana Fernandes de Santana e Silva Cardoso, MSc, Isabela da Costa César, PhD, Gerson Antônio Pianetti, PhD
Page: 94-6Abstract: 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 for these complex drugs will ensure that evidence of safety and efficacy is obtained before approval. Biosimilars are high on the health-policy agenda because they […]
Why bioequivalence and unconditional interchangeability of generic drugs are not the same
Author(s): Professor Teun van Gelder, MD, PhD
Page: 83-5Abstract: 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 individual physicians have given their opinions on the issue of generics substitution. In this issue of GaBI Journal, several hot topics related to implementation of […]
Biosimilars in oncology: current and future perspectives
Author(s): Matti Aapro, MD
Page: 91-3Abstract: 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 the development and production of similar biological medicines, or biosimilars. Biosimilars are currently available for use in oncology in the supportive care setting; the focus […]
