Assessing the impact of substandard copy medicines in developing countries: the experience with imatinib copies

Anna Kaltenboeck, Genia Long, Eleanor Hayes-Larson, Gilberto De Lima Lopes

Research output: Contribution to journalReview articlepeer-review

Abstract

Access to safe, high-quality medicines is an important international healthcare issue. In developing countries, copy medicines may be attractive due to low acquisition price, but their potential risks due to inadequately demonstrated bioequivalence have garnered only limited attention. As a result, policy-makers, physicians and patients may have incomplete information regarding their real-world safety and efficacy. Using chronic myeloid leukemia (CML) treatment as an example, we conducted a literature review of case reports and study publications to assess whether the available literature provides evidence on the real-world safety and efficacy of imatinib copies. While several publications described clinical outcomes with imatinib copy treatment, significant gaps in interpretability and quality exist. We conclude that clear demonstration of bioequivalence is critical for copy drugs, and in the presence of uncertain bioequivalence, greater pharmacovigilance and real-world data benchmarked against originator medications are needed to assess the impact of copy medicines and protect patients in developing countries.

Original languageEnglish (US)
Pages (from-to)691-701
Number of pages11
JournalExpert Review of Clinical Pharmacology
Volume6
Issue number6
DOIs
StatePublished - 2013

Keywords

  • chronic myeloid leukemia
  • copy drugs
  • developing countries
  • imatinib
  • substandard medicine

ASJC Scopus subject areas

  • Pharmacology, Toxicology and Pharmaceutics(all)
  • Pharmacology (medical)

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