title: Assessing the impact of substandard copy medicines in developing countries: the experience with imatinib copies.
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.
authors.affiliation: Analysis Group, Inc., New York, NY, USA.
authors.forename: Anna
authors.initials: A
authors.lastname: Kaltenboeck
authors.forename: Genia
authors.initials: G
authors.lastname: Long
authors.forename: Eleanor
authors.initials: E
authors.lastname: Hayes-Larson
authors.forename: Gilberto de Lima
authors.initials: Gde L
authors.lastname: Lopes
mesh_terms: D000970:Antineoplastic Agents / Q000009:adverse effects / Q000737:chemistry* / Q000494:pharmacology*; D001549:Benzamides / Q000009:adverse effects / Q000737:chemistry* / Q000494:pharmacology*; D003906:Developing Countries; D006801:Humans; D000068877:Imatinib Mesylate; D010879:Piperazines / Q000009:adverse effects / Q000737:chemistry* / Q000494:pharmacology*; D011634:Public Health; D011743:Pyrimidines / Q000009:adverse effects / Q000737:chemistry* / Q000494:pharmacology*; D011786:Quality Control
chemical_list: D000970:Antineoplastic Agents; D001549:Benzamides; D010879:Piperazines; D011743:Pyrimidines; D000068877:Imatinib Mesylate