An evolving role for non-governmental organizations dealing with registration backlogs and rising costs: the example of cancer biosimilars in South Africa

Abstract

Around the world, especially in low- and middle-income countries, national regulatory authorities are struggling with registration backlogs and the affordability of medicines. This paper draws on the example of cancer biosimilars in South Africa to illustrate how non-governmental organizations can help regulatory authorities decide which registration applications to prioritize by providing information on clinical need, cost-benefit analysis and insight into the potential for cost reduction through biosimilar competition.