Meeting Regulatory Requirements for Drugs with a Narrow Therapeutic Index: Bioequivalence Studies of Generic Once-Daily Tacrolimus

Despite growing clinical confidence in generics and their potential to reduce long-term healthcare costs, the transplant community have had real concerns about the use of generic immunosuppressants. One such immunosuppressant is tacrolimus, a cornerstone of lifelong treatment for patients who have u...

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Bibliographic Details
Published in:Drug, healthcare and patient safety healthcare and patient safety, 2020-01, Vol.12, p.151-160
Main Authors: Gantar, Kaja, Škerget, Katja, Mochkin, Ilya, Bajc, Aleksander
Format: Article
Language:English
Subjects:
Bioequivalence
Cost control
Drug approval
FDA approval
generic
Generic drugs
Health aspects
Health care costs
Kidney transplants
Laws, regulations and rules
Liver
narrow therapeutic index
once-daily
Organ transplantation
Patients
Physicians
Prescription drugs
Regulatory approval
Regulatory compliance
Tacrolimus
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Summary:Despite growing clinical confidence in generics and their potential to reduce long-term healthcare costs, the transplant community have had real concerns about the use of generic immunosuppressants. One such immunosuppressant is tacrolimus, a cornerstone of lifelong treatment for patients who have undergone a solid organ transplant. Tacrolimus has a narrow therapeutic index (NTI), giving rise to questions about the potential for clinically relevant altered drug exposure. Its use in transplant patients also gives rise to questions about the most discriminative subject population for bioequivalence studies. The recognised need for stringent criteria to support approval of generic drugs with an NTI led the European Medicines Association and Health Canada to provide detailed information on requirements for bioequivalence studies and introduce tighter bioequivalence limits for these drugs, including tacrolimus. The aim of this article is to illustrate how regulatory guidance is implemented during the clinical development of generic immunosuppressants, using a generic, once-daily prolonged-release formulation of tacrolimus as an example.
ISSN:1179-1365
1179-1365
DOI:10.2147/DHPS.S256455