The role of generics in transplantation: TM-MMF versus cellcept in healthy volunteers

Masri, Marwan; Andrýsek, Tomáš; Rizk, S; Matha, V.

doi:10.1016/j.transproceed.2003.11.008

Cited by 11 publications

(9 citation statements)

References 6 publications

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“…The dose‐normalized MPA area under the time–concentration curves (AUC) were not significantly different, and the authors concluded that the two drugs could be used interchangeably without any safety concerns. This echoes findings from a couple of small studies comparing generic and innovator MMF in healthy and post‐transplant adults, which have seen good clinical results with both drugs .…”

supporting

confidence: 77%

The problem with generic immunosuppressants

Filler

Kobrzyński

2014

Pediatric Transplantation

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supporting

confidence: 77%

The problem with generic immunosuppressants

Filler

Kobrzyński

2014

Pediatric Transplantation

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“…Bioequivalence is defined as the absence All approved products, both brand and generic, are listed in FDA's Approved Drug Products with Therapeutic Equivalence Evaluations (known as the 'Orange Book'). Tacrolimus, CYA, mycophenolic acid, AZA and prednisone are available as generic drugs, and in the USA generics account for as much as 20% of the market-share of CYA [24][25][26]. Since immunosuppression may have a narrow therapeutic index in terms of its ability to prevent rejection, and generic BA and BE are only assessed in normal volunteers, the actual effect of generics in the transplant population are not necessarily well defined [23,26].…”

Section: Cost-lowering Strategiesmentioning

confidence: 99%

Cost-Effective Immunosuppressive Options for Solid Organ Transplantation: A Guide to Lower Cost for the Renal Transplant Recipient in the USA

Farney

Doares²,

Kaczmorski³

et al. 2010

Immunotherapy

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Of the numerous risks associated with immunotherapy for the prevention of rejection, cost is perhaps the most universal. In the USA and some other countries, the costs of immunosuppression make transplantation unavailable for some medically viable transplant candidates, and for others who receive a transplant, the long-term costs are economically crippling. Minimization and tapering of immunosuppression, use of generics, manipulation of metabolism, infection surveillance instead of prophylaxis, and advantageous routes of administration are some strategies that can be employed to reduce immunotherapy expense. Using these strategies, we describe an immunosuppression regimen for kidney transplantation that might be only a third of the cost of current 'standard' regimens in the USA. Such a regimen might allow some patients who might not otherwise qualify economically to safely receive a kidney transplant. The purpose of creating an alternative, lower-cost immunotherapy regimen is to give patients a choice. Responsible stewardship of scarce donor organs is the primary, and clearly appropriate, limiting factor.

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“…Five pharmacokinetic studies utilizing generic mycophenolate mofetil were identified, of which three studies enrolled healthy subjects in concordance with regulatory standards for bioequivalency studies. [16][17][18] The remaining two studies were conducted in stable renal allograft recipients. 19,20 All studies were conducted outside the United States using generic products manufactured outside the United States; however, some of the manufacturers produce generics for use in the United States.…”

Section: Pharmacokinetic Studiesmentioning

confidence: 99%

“…The least squares mean values, following a single 1-g dose, for the AUC 0-t (mg Â h/mL) were 23.68 versus 24.35 and Cmax (mg/mL) 19.83 versus 18.91 for mycophenolate (note 4) and CellCept (note 5), respectively (P ¼ NR). 17 The second study reported the least squares mean values, following a single 500-mg dose, for the AUC 0-t (mg Â h/mL) as 11.65 versus 11.06 and Cmax (mg/mL) 12.20 versus 11.68 for mycophenolate mofetil (note 6) compared to CellCept (note 7), respectively (P ¼ NR). The authors report that the products achieved the FDA standards for bioequivalence, however, the 90% CI were not included in the publications.…”

Section: Healthy Subjectsmentioning

confidence: 99%

Is There Evidence to Support Brand to Generic Interchange of the Mycophenolic Acid Products?

Phillips

Gabardi

2016

Journal of Pharmacy Practice

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The uptake of generic immunosuppressants lags comparatively to other drug classes, despite that the Food and Drug Administration (FDA) uses identical bioequivalence standards for all drugs. Transplant societies acknowledge the cost savings associated with generic immunosuppressants and support their use following heart, lung, kidney, or bone marrow transplantation. Seven studies of the pharmacokinetics or clinical efficacy of generic mycophenolate mofetil compared to the innovator product are published; all studies and products were ex-United States. Three studies did not demonstrate any pharmacokinetic differences between generic and innovator products in healthy subjects, achieving FDA bioequivalence requirements. Two studies in renal allograft recipients demonstrated no difference in area under the curves between generic and innovator products, and in one, the maximum concentration (Cmax) fell outside the FDA regulatory range. Two studies revealed no difference in acute organ rejection or graft function in renal allograft recipients. Patient surveys indicate that cost is a barrier to immunosuppressant adherence. Generics present a viable method to reduce costs to payers, patients, and health care systems. Adherence to immunosuppressants is crucial to prevent graft failure. An affordable regimen potentially confers greater adherence. Concerns regarding the presumed inferiority of generic immunosuppressants should be assuaged by regulatory requirements for bioequivalency testing, transplant society position statements, and pharmacokinetic and clinical studies.

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The role of generics in transplantation: TM-MMF versus cellcept in healthy volunteers

Cited by 11 publications

References 6 publications

The problem with generic immunosuppressants

The problem with generic immunosuppressants

Cost-Effective Immunosuppressive Options for Solid Organ Transplantation: A Guide to Lower Cost for the Renal Transplant Recipient in the USA

Is There Evidence to Support Brand to Generic Interchange of the Mycophenolic Acid Products?

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