Dr Zafer Başlar (Istanbul University, Istanbul, Turkey) presented the results of a multicentre study that was conducted in Turkey to evaluate the efficacy and tolerability of generics for CML patients.

The high cost of tyrosine kinase inhibitors developed for chronic myeloid leukaemia is a major concern for the health care payers, especially in countries with restricted resources.

It is true that generics lead to considerable cost savings but they also give rise to questions associated with their efficacy, safety and quality.

The aim of this multicentre study was to evaluate the efficacy and tolerability of generics, and to compare these with the original molecule when used in patients with chronic phase chronic myeloid leukaemia as initial treatment.

There were two study groups, Group A consisted of thirty-six patients who received the original imatinib (Gilvec, Novartis), and 26 patients in which a generic was initiated (Group B).

The two groups were comparable regarding age, gender, and risk scores.

There was no significant difference between the groups regarding response and resistance rates, and the rates of haematological and non-haematological adverse events

Among Başlar et al's patient cohort, the generics were at least non-inferior to the original molecule regarding efficacy and tolerability.

In Turkey, each box of generic imatinib (400 mg/day, 30 tablets) is approximately €100 cheaper than the original molecule.

This may result in a cost saving of €12,000,000 per 10,000 chronic phase chronic myeloid leukaemia patients per year (approximately €30,000 per day).

Prospective randomised trials with larger number of patients are needed to address the efficacy of generics compared with imatinib in patients with chronic myeloid leukaemia.

Source: EHA