Bioequivalence of generic cyclosporine

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Bioequivalence of generic cyclosporine

Generics/Research | Posted 29/04/2011 0 Post your comment

A clinical trial in allogeneic stem cell transplant (ASCT) recipients found that generic and branded cyclosporine could be considered interchangeable.

Cyclosporine (or ciclosporin) is an immunosuppressant drug widely used in post-allogeneic organ transplant to reduce the activity of the patient’s immune system, and therefore the risk of organ rejection.

Bioequivalence of Equoral (generic cyclosporine, Teva) to Neoral solution (branded cyclosporine, Novartis) has been suggested by measurements of pharmacokinetic parameters in healthy volunteers and in stable renal transplant recipients, however had not been studied in ASCT recipients.

This study enrolled 30 ASCT patients in an open two-way cross-over design from June 2007 to November 2008, with a seven to 14-day test period for assessment of the pharmacokinetic parameters Cmax (extent of absorption), tmax (rate of absorption) and AUC0-12h (area under the concentration-time curve).

The pharmacokinetic parameters were found to be similar between the generic and branded versions and comparable toxicities and rates of graft-versus-host disease were recorded in both groups.

The authors therefore suggest that generic and branded cyclosporine can be considered interchangeable in ASCT recipients.

Reference

Tareka BO, Nadia BF, Anis K, et al. Assessment of bioequivalence of a generic cyclosporine (Equoral) by a prospective randomized controlled trial on allogeneic stem cell transplant recipients. Transplant Proc. 2010;42(9):3735-8.