The role of generic medicines and biosimilars in oncology in low-income countries.

Cancer cases are rising in developing countries which are already grappling with high levels of infectious diseases including human immunodeficiency virus/acquired immunodeficiency syndrome (HIV/AIDS), tuberculosis (TB) and malaria. The United Nations (UN) including the World Health Organisation (WHO) have called on member states to establish strategies to deal with the increasing burden of non-communicable diseases, including cancer, in developing countries. The complexity of cancer care and management calls for innovative approaches in low resource settings especially since these settings are already grappling with huge challenges in healthcare including lack of funds, weak human resource base and lack of treatment guidelines. Whilst the cost of medications is by no means the only high cost in cancer care, the availability of affordable anti-cancer generic drugs and biologically similar therapeutic agents (biosimilars) will go a long way to reduce overall cost of cancer care. The high cost of anticancer medicines has been cited among the reasons whilst patients default in treatment. Non-proprietary anti-cancer agents--generics and biosimilars--often cost several times lower than their innovator branded counterparts. They can reduce the cost of care significantly and their multi-source origin often provide guarantee in supply. The use of generic and biosimilar products is hinged on the assumption that they are of assured quality and of the same pharmaceutical integrity as their innovator counterparts. The use of these products however is associated with challenges that must be understood and addressed. The quality of all generics and biosimilars should be rigorously controlled and assured. Measures to prevent counterfeit and sub-standard generics and biosimilars should be developed and the cold-chain must be maintained for all biosimilars. In addition to these, the WHO is encouraged to develop a prequalification scheme to assist countries without strong regulatory systems to procure anticancer generics and biosimilars of assured quality.