biological efficacy

Imatinib Generics: Myths and Reality (Literature Review and Our Experience)

CLINICAL PRESENTATION, DIAGNOSIS, AND MANAGEMENT OF MYELOID MALIGNANCIES , , , ,

K.M. Abdulkadyrov, V.A. Shuvaev, M.S. Fominykh

Russian Research Institution of Hematology and Transfusiology, FMBA, Saint Petersburg, Russian Federation

For citation: Abdulkadyrov K.M., Shuvaev V.A., Fominykh M.S. Imatinib Generics: Myths and Reality (Literature Review and Our Experience). Klin. onkogematol. 2014; 7(3): 311–6 (In Russ.).

ABSTRACT

The article describes the registration process of generic drugs in the Russian Federation. The article presents literature data and results of our own studies of the use of imatinib generics — PhilachromineÒ and GenfatinibÒ — in patients with chronic myelogenous leukemia. The tolerability (incidence of adverse events) and therapeutic efficacy (the number of optimal responses to therapy) were analyzed in comparison with historical control of patients, treated with GlivecÒ. 14 patients with chronic myeloleukemia treated with Philachromine® as a first-line treatment and 81 patients previously treated with GlivecÒ (54 of them received PhilachromineÒ and 27 patients received GenfatinibÒ) were included in study. Therapeutic efficacy and tolerability of generics (PhilachromineÒ and GenfatinibÒ) were similar to those of GlivecÒ within the compared observation period.

Keywords: chronic myeloleukemia, tyrosine kinase inhibitors, imatinib, generics, generic substitution, biological efficacy.

Address correspondence to: shuvaev77@mail.ru

Accepted: May 21, 2014

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