Assessment of the Bioequivalence of a Generic Cyclosporine A by a Randomized Controlled Trial in Stable Renal Recipients

Hibberd, A. D.; Trevillian, Paul; Roger, Simon D.; Wlodarczyk, John; Stein, Ann M.; Bohringer, E G.; Milson-Hawke, Sally

doi:10.1097/01.tp.0000181198.98232.0c

Cited by 26 publications

(28 citation statements)

References 33 publications

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“…Nevertheless, the Food and Drug Administration (FDA) considers Gengraf TM to be bioequivalent and interchangeable with Neoral Ò [35]. Similarly, a bioequivalence study comparing a generic ciclosporin with its counterpart brand drug Neoral Ò found that the extent and rate of absorption of the former were significantly lower than those of Neoral Ò [36]. Since generic and therapeutic substitution can be faced with uncertain risks, the 'precautionary principle' should be taken as an absolute rule [37].…”

Section: Discussionmentioning

confidence: 99%

Generic and therapeutic substitutions: are they always ethical in their own terms?

2010

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Cost containment-driven drug substitution, whether generic or therapeutic, is defined as switching to another drug because it is cheaper. So far, such substitutions have drawn their public legitimacy from the general belief that they would not compromise the clinical interests of patients and certainly not violate their right to decline them if they did. This article does not enter the debate on whether or not such substitutions must give exclusive priority to the patient's interests and choices in order to be ethical. Indeed, it acknowledges the plurality of views on this matter. It simply argues that when such substitutions involve a cheaper drug that is known to have different effects and side effects, or even a drug whose effects and side effects are unknown, they are potentially deleterious to the patient, and that no competent and well-informed patient would ever consent to them. Such substitutions are thus unethical in their very own terms.

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Section: Discussionmentioning

confidence: 99%

Generic and therapeutic substitutions: are they always ethical in their own terms?

2010

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“…Other studies showed differences in the pharmacokinetic profile between branded and generic medicines, disparities that might affect clinical outcomes [38][39][40]. In addition, a bioequivalence study comparing a generic ciclosporin with its counterpart branded drug Neoral Ò (Novartis Pharmaceuticals UK Ltd, Surrey, UK) found that the extent and rate of absorption of the former were significantly lower than those of the latter [41]. Similarly, another study compared the biopsy-proven rate of acute rejection (BPAR) at 6 months after kidney transplantation between the branded immunosuppressant drug Neoral Ò and the branded-generic GengrafÔ (Abbott Laboratories, North Chicago, IL, USA).…”

Section: Renal Transplant Patients' Views On Generic Substitution In mentioning

confidence: 99%

A survey to determine the views of renal transplant patients on generic substitution in the UK

Ameri

Whittaker

Tucker

et al. 2011

Transplant International

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Summary Rising healthcare costs promote the generic substitution among patients because it is identifiable costs. A key concern is that patients should be involved in the decision of switching. The aim of this study was to examine renal transplant patients’ views on generic substitution in the UK. A total of 163 renal patients were surveyed using 36 multiple‐choice questions at Barts and The London Renal Transplant Clinic, in the UK. Transplant recipients over 18 years, able to read and write English and willing to fill in the questionnaire were targeted; 84% of patients were conscious of the availability of generic medicines, 70% understood the terms “generic” and “branded” in relation to medicines and 54% were aware of generic substitution practice. However, 75% did not know if they were taking generics and 84% felt that generics are not equivalent or only equivalent sometimes and they were uncertain that generics had the same quality as branded medicines. Moreover, many patients admitted that they would not accept the generic substitution of ciclosporin when become available in the UK. A number of factors such as patients’ education, knowledge, severity of the disease, efficacy of generic medicines and patients’ involvement in decisions regarding their health appear to drive patients’ attitudes towards generic substitution.

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“…However, transplant societies have raised concerns regarding the validity of extrapolating data derived from healthy subjects to the target patient populations [8][9][10] . Indeed, although most of the generic CsA conversion trials in stable renal transplant recipients found the tested products to have similar pharmacokinetic profiles compared to Neoral [11][12][13][14] , few others have reported significant differences between generic and innovator products [15,16] . Along the same line, in the de novo kidney transplant setting, some studies found similar renal graft outcomes with Neoral or generic CsA formulations [17,18] , whereas others indicated a higher rate of acute rejection with generic products [19,20] .…”

Section: Introductionmentioning

confidence: 99%

Conversion from Brand-Name Neoral to the Generic Ciqorin in Stable Renal Transplant Recipients

Cortinovis

Gotti

Trillini

et al. 2016

Nephron

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Background/Aims: Transplant physicians and patients are often reluctant to change to generic versions of immunosuppressive drugs with a narrow therapeutic index, such as ciclosporin (CsA). Thus, in routine follow-up for kidney transplant patients receiving CsA maintenance immunosuppressive therapy in our center, we evaluated the exchangeability of the brand name, Neoral, and the recently approved CsA generic formulation, Ciqorin. Methods: We assessed the complete 12-h CsA pharmacokinetic profile and direct measurement of glomerular filtration rate (mGFR) of 10 patients receiving stable doses of Neoral (138 ± 43 mg/day), at least 6 months after kidney transplantation (Neoral 1). The same evaluations were repeated 10 days after conversion to Ciqorin on a milligram-to-milligram basis and 10 days after reinstituting Neoral (Neoral 2). Results: The mean CsA area under the concentration-time curve increased slightly after switching from Neoral to Ciqorin (p = 0.03), but did not change significantly after Neoral was reintroduced (Neoral 1: 2,234 ± 783, Ciqorin: 2,452 ± 767, Neoral 2: 2,472 ± 784 ng × h/mL). There were no appreciable differences between the 2 CsA formulations in trough levels, maximum concentrations, or time to reach maximum concentrations. In all patients, renal function remained stable throughout the monitoring period (mGFR, Neoral 1: 52.0 ± 16.2; Ciqorin: 55.0 ± 19.0; Neoral 2: 55.8 ± 18.9 mL/min/1.73 m²), as did urinary and hematochemical parameters. Conclusions: In stable kidney transplant recipients, switching from Neoral to Ciqorin resulted in similar pharmacokinetic parameters and did not change renal allograft function, reassuring physicians and patients regarding the exchangeability of reference and generic CsA formulations.

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Assessment of the Bioequivalence of a Generic Cyclosporine A by a Randomized Controlled Trial in Stable Renal Recipients

Cited by 26 publications

References 33 publications

Generic and therapeutic substitutions: are they always ethical in their own terms?

Generic and therapeutic substitutions: are they always ethical in their own terms?

A survey to determine the views of renal transplant patients on generic substitution in the UK

Conversion from Brand-Name Neoral to the Generic Ciqorin in Stable Renal Transplant Recipients

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