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

Abstract

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.

Drug waste minimization as an effective strategy of cost-containment in Oncology

“…Secondly, we did not considered the impact of oral high-cost drugs on drug expenditures, which may need a specific protocol to evaluate the amount of drug waste and related costs and ad-hoc measures to reduce them. Moreover we have to consider that, in the near future, the fraction of iv drugs will proportionally decrease, and the availability of biosimilar cancer drugs will also help reducing the costs [24,25] Finally, after a significant decrease in wastage costs during the first year of application of the protocol, the benefit tends to reach a plateau, with smaller savings during the second and third year. On the other hand this can be positively interpreted as the ability of the system to maintain its steady state after the first phase of optimization, supporting the robustness of our measures with time.…”

Proposing Essential Medicines to Treat Cancer: Methodologies, Processes, and Outcomes

“…In addition, any costing data presented referred only to the cost of the antineoplastic medicines and did not take into consideration the cost of ancillary medications, such as antiemetics, or the cost of provision of care or other components of care, such as surgery or radiation, all of which are important as well. This area of research has received scant attention, and more investigation is highly needed, [53][54][55] as Abbreviations: ATRA, all-trans-retinoic acid; G-CSF, granulocyte colony-stimulating factor. *New medication.…”

Perceptions and Challenges for Adoption of Generics and Biosimilars in Oncology

“…Generic medicines are lesser priced when compared to the innovator products and offer affordable options in management of various disease conditions including cancer [4,13]. This has special relevance in low-income countries as it improves access and compliance to therapeutic options.…”

“…These practices need to be standardized and implemented as nation-wide initiatives for successful utilization of generics. Efforts should be made to develop and design a prequalification scheme to assist countries lacking strong regulations in procurement of anticancer generics and biosimilars of assured quality [13].…”