Access to liposomal generic formulations: beyond AmBisome and Doxil/Caelyx
The lack of clear regulatory guidance remains a key bottleneck for securing a second quality-assured source of liposomal amphotericin B (LAmB) , the WHO-recommended drug for visceral leishmaniasis (VL). The approval of the first generic liposomal product by the US Food and Drug Administration in February 2013 could be a turning point, and serve as a basis for WHO to develop guidance for the evaluation of generic liposomal formulations.
Liposomal amphotericin B injectable (LAmB) is the reference drug for treatment of presumptive fungal infections in patients with febrile neutropenia, systemic fungal infections refractory to conventional amphotericin B, or visceral leishmaniasis (VL) [1-3]. Visceral leishmaniasis is a parasitic neglected disease which is fatal if left untreated. Although LAmB is included in the World Health Organization (WHO) Essential Medicines List [4, 5], it is difficult to access in many countries.
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