The WHO prequalified list8currently includes 2 formulations of single-dose DTG. One is from the originator company prequalified by WHO in 2014, and the other is from a generic manufacturer recently tentatively approved by the United States Food and Drug Administration (FDA)9.The WHO Prequalification of Medicines Programme is assessing a generic version of tenofovir (TDF) + lamivudine (3TC) + DTG, with the results expected by the end of 2017. More submissions of DTG both single and fixed-dose generic formulations are expected in the next 2 years10.
By the end of 2017, DTG 50 mg single-dose formulations are expected to be registered in 56 countries, and DTG-containing fixed-dose combinations in 38 countries. The time needed to obtain local registration (or a waiver) is likely to be one of most important factors determining the pace at which programmes can transition to new formulations.
8: Essential medicines and health products: prequalification of medicines. Prequalified lists of medicines/finished pharmaceutical products. Geneva: World Health Organization; 2017 (https://extranet.who.int/prequal/content/prequalified-lists/medicines, accessed 1 July 2017
9: Aurobindo Pharma receives USFDA tentative approval for dolutegravir. Boston: Clinton Health Access Initiative;2016 (http://www.clintonhealthaccess.org/usfda-tentativeapproval-dolutegravir, accessed 1 July 2017).
10: ARV market report: the state of the antiretroviral drug market in low- and middle-income countries, 2015– 2020. Issue 7, October 2016. Boston: Clinton Health Access Initiative; 2016 (http://www.clintonhealthaccess.org/content/uploads/2016/10/CHAI-ARV- Market- Report-2016-.pdf, accessed 1 July 2017).