Pharmaceutical and therapeutic equivalence study of the generic drug containing bezafibrate

Susumu Kaneshige, Yuusuke Ikeda, Matsunaga Naoya, Koyanagi Satoru, Shigehiro Ohdo, Hidetoshi Kamimura

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Abstract

Objectives: The use of generic drugs is recommended in order to reduce medical costs. However, many doctors and pharmacists do not trust the quality, efficacy and safety of some generic drugs. Bezator® SR containing bezafibrate is widely used for the treatment of hyperlipidemia, and besastar® SR is the generic drug of bezator® SR. We herein compared the pharmaceutical and therapeutic equivalence of besastar® SR with those of bezator® SR. Methods: The elution rate of bezafibrate from besastar® SR was compared to that of bezator® SR. In addition, the clinical data of the patients treated with besastar® SR at Fukuoka Memorial Hospital were compared with those treated with bezator® SR at Fukuoka University Chikushi Hospital. Results: One of six lots of besastar® SR did not satisfy the standards of elution of bezafibrate. However, the effect of besastar® SR on the blood triglyceride concentration after 4-12 weeks was equivalent to that of bezator® SR. In addition, in a manner similar to that of bezator® SR, besastar® SR did not induce hematopoietic injury, hepatic dysfunction, renal dysfunction or rhabdomyolysis during the period from 4-12 weeks after the initiation of treatment. Conclusions: Although besastar® SR is not 100% pharmaceutically equivalent to bezator® SR, the efficacy and safety of this generic drug are considered to be equivalent to those of bezator® SR.

Original languageEnglish
Pages (from-to)91-100
Number of pages10
JournalJapanese Pharmacology and Therapeutics
Volume39
Issue number1
Publication statusPublished - Jan 20 2011

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All Science Journal Classification (ASJC) codes

  • Pharmacology (medical)
  • Pharmacology

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