EMA approval for tacrolimus generic

Generics/News | Posted 10/11/2017 post-comment0 Post your comment

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) announced on 12 October 2017 that it had recommended granting marketing authorization for the tacrolimus generic tacforius.

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Tacrolimus is a medicine that inhibits the activation of the serine-threonine phosphatase, calcineurin, in T lymphocytes. This suppresses T lymphocyte activation and the subsequent generation of cytotoxic lymphocytes, thereby down regulating processes leading to acute graft rejection.

Tacrolimus is the primary immunosuppression drug used in kidney and liver transplant patients. It is also a drug with a narrow therapeutic index. Such drugs are defined by a narrow distance between the dosage that induces a desired effect and that dosage which already has a toxic effect [1].

Following organ transplantation, patients require lifelong treatment with immunosuppressants. Many transplant patients are faced with complicated post-transplant medication regimens and significant financial burden.

The generic tacrolimus, tacforius, is made by Teva Pharmaceutical Industries and is a generic version of the brand-name tacrolimus, Advagraf, which is made by Astellas Pharma and has been approved in the European Union since 25 April 2007.

The CHMP approved tacforius prolonged-release capsules in dosages of 0.5, 1, 3 and 5 mg, saying that studies of the generic ‘demonstrated the satisfactory quality of Tacforius, and its bioequivalence to the reference product Advagraf’. 

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1. GaBI Online - Generics and Biosimilars Initiative. Follow-up study finds generic tacrolimus safe for kidney transplant patients [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Nov 10]. Available from: www.gabionline.net/Generics/Research/Follow-up-study-finds-generic-tacrolimus-safe-for-kidney-transplant-patients

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Source: EMA

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