Search results for immunosuppression

Commentary on the recommendations of the European Society for Organ Transplantation Advisory Committee on generic substitution of immunosuppressive drugs

Abstract: In 2010, the Council of the European Society for Organ Transplantation formed an Advisory Committee to formulate recommendations on the use of generic drugs in solid organ transplant recipients. The initiative was taken as a result of concerns regarding generic substitution of immunosuppressive drugs. The recommendations were published in Transplant International, and this paper […]

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

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 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 […]

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

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 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 […]

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