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Master Thesis

Utilisation des immunosuppresseurs génériques dans la transplantation rénale‎ : quel avenir ?

Abstract : Generic medicines occupy an important position in the French healthcare system as well as international ones. Public authorities encourage their use as they allow to save money on a yearly basis. This encouragement shouldn't lead to a systematic substitution in the event that the patient's health could be jeopardized. It is especially true for the medicines with a narrow therapeutic index like immunosuppressants. Thus the use of the first generic immunosuppressant available in France in renal transplant: the "mycophénolate mofétil", is subject to controversy. Only bioequivalence studies on a healthy volunteer are performed for the drug approval. These studies can hardly be extrapolated to the drug's target population. This is particularly true in the case of "mycophénolate mofétil" that presents intra- and interindividual variabilities; and a small change of exposure for patients could lead to adverse effects and rejection that might end up with the loss of the graft. Learned societies emit recommendations for the use of generic immunosuppressants but caution and setting up of close medical, biological and therapeutic follow-up care is required in the first phase of the substitution of Cellcept® by its generics in order to ensure the security of our patients. In a second phase, we will have to measure the actual savings that their use will enable, assess the safety of prescribing them, and draw conclusions for future use of generic immunosuppressants like "ciclosporine" and "tacrolimus" that have already been marketed in other countries.
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Master Thesis
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Submitted on : Wednesday, October 23, 2013 - 2:48:37 PM
Last modification on : Tuesday, May 11, 2021 - 11:36:17 AM
Long-term archiving on: : Friday, January 24, 2014 - 4:24:26 AM


  • HAL Id : dumas-00875797, version 1
  • PPN : 172393434


Pierre-Alexandre Bourbon. Utilisation des immunosuppresseurs génériques dans la transplantation rénale‎ : quel avenir ?. Sciences pharmaceutiques. 2013. ⟨dumas-00875797⟩



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