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Generic tacrolimus in solid organ transplantation
Author(s) -
Taube D.,
Jones G.,
O'Beirne J.,
Wennberg L.,
Connor A.,
Rasmussen A.,
Backman L.
Publication year - 2014
Publication title -
clinical transplantation
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.918
H-Index - 76
eISSN - 1399-0012
pISSN - 0902-0063
DOI - 10.1111/ctr.12336
Subject(s) - tacrolimus , medicine , innovator , organ transplantation , transplantation , bioequivalence , kidney transplantation , intensive care medicine , lung transplantation , pharmacology , surgery , pharmacokinetics , intellectual property , computer science , operating system
The availability of a wide range of immunosuppressive therapies has revolutionized the management of patients who have undergone solid organ transplantation ( SOT ). However, the cost of immunosuppressive drugs remains high. This situation has led to the development of generic equivalents, which are similar in quality, safety, and efficacy to their approved innovator drugs. There are data available for three generic brands, tacrolimus (Intas), tacrolimus (Phar OS ), and tacrolimus (Sandoz). Bioequivalence has been demonstrated for generic tacrolimus (Sandoz) within a narrow therapeutic range to its innovator tacrolimus drug (Prograf) in both healthy volunteers and kidney transplant patients. Clinical experience with this generic tacrolimus formulation has also been established in both de novo and conversion patients who have undergone kidney and liver transplantation, as well as in conversion of other SOT patients, including lung and heart recipients.