Generic AmBisome

AmBisome®, an effective but expensive treatment for VL, is still under patent protection in the US until 2016 but no longer in Europe. Several producers in India and elsewhere are in the process of developing generic versions of AmBisome®; however, a thorough analysis on the composition of new products, their physico-chemical characteristics, quality assurance, and GMP production is needed to assess whether these products have the qualifications to characterize a potential generic version of AmBisome®. At present, WHO has not set any standards for the regulatory evaluation of liposomal drugs and there is a lack of regulatory guidance in stringently regulated countries. A second producer of quality-assured, liposomal amphotericin B would ensure treatment availability for the next decade, particularly given Gilead’s past problems (batch recall in 2013), and hopefully competition would lead to lower prices.

With the prospect of an alternative FDA-approved generic AmBisome® being available shortly, together with falling numbers of patients in Asia whose needs are adequately covered by a Gilead donation programme through the WHO, this project has been put on indefinite hold.