Published in:
Volume 2 / Year 2013 / Issue 2

Biosimilarity in Latin America

Author(s): , , , ,
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

Page: 91-3

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): , ,
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

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 »

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