Generic Transplant Drugs as Effective as Brand Name Treatment

Promising results from generic formulation of drug used post-transplant to reduce the risk of organ rejection.

A generic version of a post-transplant drug used to reduce the risk of organ rejection was found to be as strong as the brand name formulation, according to a recent study.

Presented at the 2015 American Transplant Congress annual meeting in Philadelphia, a University of Cincinnati-led research team found the generic version of tacrolimus to be a promising option for transplant patients.

The prospective, blinded, six-way crossover study included kidney and liver transplant patients to evaluate whether the 2 most disparate generics are bioequivalent to the drug tacrolimus (Prograf) in stable transplant patients based on potency, purity, and dissolution.

The researchers examined 70 patients who received a transplant at either the University of Cincinnati Medical Center or The Christ Hospital (Cincinnati) transplant programs. Patients either received brand name tacrolimus or 1 of 2 generic versions of the drug.

"We found there to be essentially no difference in the formulations between the generics and brand-name version," said lead investigator Rita Alloway, PharmD, in a press release. "In other words, if you were on brand and switched to generic--and you take your medication as instructed--there should be no clinical consequence."

The findings are significant due to the fact that more than 70% of tacrolimus that is dispensed is the generic version, which has no consistent negative reports, according to the study. However, concerns persist among physicians and patients over the use of generic drugs following a transplant.

"Most immunosuppressant drugs require individualized dosing and careful management to ensure the proper blood concentrations are maintained," Alloway said. "Too high exposure to these drugs increases the risk of toxicity, over-immunosuppression and cancer in patents. Too low exposure may lead to rejection of the organ by the patient's immune system."