TY - JOUR
T1 - Assessing the impact of substandard copy medicines in developing countries
T2 - the experience with imatinib copies
AU - Kaltenboeck, Anna
AU - Long, Genia
AU - Hayes-Larson, Eleanor
AU - De Lima Lopes, Gilberto
N1 - Funding Information:
Funding for this research was provided by Novartis Pharmaceuticals, East Hanover, NJ, USA. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.
PY - 2013
Y1 - 2013
N2 - 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.
AB - 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.
KW - chronic myeloid leukemia
KW - copy drugs
KW - developing countries
KW - imatinib
KW - substandard medicine
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U2 - 10.1586/17512433.2013.843450
DO - 10.1586/17512433.2013.843450
M3 - Review article
C2 - 24147557
AN - SCOPUS:84887290109
SN - 1751-2433
VL - 6
SP - 691
EP - 701
JO - Expert Review of Clinical Pharmacology
JF - Expert Review of Clinical Pharmacology
IS - 6
ER -