As one of the world’s poorest regions, sub-Saharan Africa has suffered more than its fair share of disease and deprivation. As efforts to treat communicable diseases prove successful and childhood mortality decreases, the burden of disease in the region is slowly changing. More chronic health conditions are now evident – in particular, cancer and diabetes – putting a greater strain on already fragile healthcare systems that struggle to afford even a fraction of the cost of biologic treatments. Formal biosimilar legislation is still rare in African countries, but in 2014, regulatory experts and pharmaceutical industry representatives from 11 African countries convened to discuss the implications of biosimilar development and introduction across the region, indicating new momentum in this area.
Understanding the need for biologics in sub-Saharan Africa needs to start with insights into the changing face of healthcare within this region. Africa has a higher proportion of countries defined as ‘low income’ than any other region in the world. While accounting for less than 1% of global health expenditure, World Health Organization (WHO) statistics show that sub-Saharan Africa carries around a quarter of the global burden of disease.1 In addition, the pattern of disease in Africa has started to change in recent years. With the exception of HIV/AIDS, significant declines in mortality have been reported for most of the principal infectious diseases. At the same time, longer life expectancy and the adoption of more Western lifestyles has meant that the burden of non-communicable diseases, particularly cancer, is rising faster in Africa than anywhere else.2 In 1970, developing countries were responsible for only 15% of the global cancer burden. This proportion had risen to more than 50% by 2008.3 More recent estimates suggest that almost two-thirds of the 7.6 million global annual death toll from cancer now occurs in low- and middle-income countries.3 By 2030, the countries of sub-Saharan Africa are predicted to experience a more than 85% increase in their cancer burden, with far-reaching consequences for healthcare provision.4 Another modern ‘plague’ that is rising alarmingly in parts of Africa, largely due to increasing Westernization, is diabetes. By 2035, the African diabetes population is projected to double from its current level of almost 20 million to more than 41 million.5
Traditional ‘Western’ diseases, like cancer and diabetes – now on the rise in Africa and the rest of the developing world – are where biologic treatments have made the greatest clinical impact. However, across most of Africa, the cost of medicines is a huge barrier to adequate care for non-communicable diseases.4 Many African countries struggle to pay even for conventional chemical drugs, and restrict access to medicines to those that appear on the WHO Essential Drugs list. Accordingly, across most of the sub-Saharan region, a large proportion of drug costs have to be paid for ‘out-of-pocket’ by patients. Lack of modern cancer medicines is at least partly responsible for the poorer prognosis of patients with cancer in these countries.6
Similarly, with insulin costing up to 75% of a person’s annual income in some African countries, optimal diabetes care remains out of reach for many people.5 Funds for treating chronic diseases like rheumatoid arthritis (RA) – which are not considered life-threatening – can be even more difficult to access. In sub-Saharan Africa, fewer than 1% of people with RA outside of South Africa have access to biologic treatment, and more than 30% cannot get any drug treatment for their RA at all.7 Often, targeted biologic therapies – which can make a substantial difference to quality of life – are only available to a very small minority of wealthy individuals, or via occasional pharmaceutical or biotechnology company-funded assisted access programs.8
Even in upper middle-income African countries such as South Africa, access to important biologics is restricted. For example, despite its key role in revolutionizing forms of breast cancer care, trastuzumab is only available to South African patients enrolled in clinical trials or to those with private health insurance.9 The private insurance schemes available vary in the extent to which they will pay for care; while some will cover a full year’s treatment, others will pay for only 9 weeks. Co-payment conditions are also common with biologics, putting them out of the reach of most people, and annual price limits on biologics may also restrict their use.
Most African countries have yet to establish official approval frameworks for biosimilars and are so far unable to regulate these products according to international standards. However, formal biosimilar legislation is in place in South Africa and also in Nigeria.11,12
While not confirmed, it is possible that some countries in sub-Saharan Africa may have approved or imported products known as ‘copy biologics’ – non-originator biologics that have not been assessed according to rigorous regulatory guidance (equivalent or close to international standards). Copy biologics and biosimilars should be differentiated from a regulatory perspective, but unfortunately local reports and statistics do not always reflect this differentiation.
|Country||Regulatory agency||Biosimilar regulation||Approved biosimilars*
National Agency for Food and Drug Administration and Control
|Final guidance issued December 2012.12
Medicines Control Council of South Africa
|Final guidance issued March 2012.11
|*Products approved before the date of the national regulatory guidance may not have undergone full comparability/biosimilarity testing and are considered ‘copy biologics’ rather than biosimilars.
Although not yet widely introduced, biosimilars that are appropriately priced could have an important role to play in the management of cancer and other non-communicable diseases in African countries.6
Experts have called for access to biosimilars in Africa and other developing economies, with a particular focus on their role in treating potentially curable cancers.6 In 2014, regulatory authorities from 11 African countries (Botswana, Ethiopia, Ghana, Kenya, Lesotho, Mozambique, Namibia, Nigeria, Uganda, Zimbabwe, and Zambia) met in Zimbabwe with representatives from the pharmaceutical industry, academia, the WHO, and the European Medicines Agency (EMA) to share expertise on biologics and the introduction of biosimilars within Africa. This was the first meeting of its kind and an important step forward in encouraging biosimilar research and development across the region.14
1. International Network for Cancer Treatment and Research. Cancer in developing countries. http://www.inctr.org/about-inctr/cancer-in-developing-countries/. Accessed 16 March 2015.
2. de-Graft Aikins A, Unwin N, Agyemang C et al. Tackling Africa's chronic disease burden: from the local to the global. Global Health (2010) 6:5.
3. Farmer P, Frenk J, Knaul FM et al. Expansion of cancer care and control in countries of low and middle income: a call to action. Lancet (2010) 376:1186–1193.
4. Morhason-Bello IO, Odedina F, Rebbeck TR et al. Challenges and opportunities in cancer control in Africa: a perspective from the African Organisation for Research and Training in Cancer. Lancet Oncol (2013) 14:e142–51.
5. 100 Campaign. 100 Campaign: insulin access by 2022. http://www.100campaign.org/. Accessed 28 January 2015.
6. Renner L, Nkansah FA& Dodoo ANO. The role of generic medicines and biosimilars in oncology in low-income countries. Ann Oncol (2013) 24 (Suppl 5):v29–v32.
7. Adebajo A & Gabriel SE. Addressing musculoskeletal health inequity in Africa. Arth Care Res (2010) 62:439–441.
8. Kingham TP, Alatise OI, Vanderpuye V et al. Treatment of cancer in sub-Saharan Africa. Lancet Oncol (2013) 14:e158–67.
9. Biosimilar News, 22 June 2012. Mabthera prices get lower in South Africa. http://www.biosimilarnews.com/mabthera-prices-get-lower-in-south-africa. Accessed 16 March 2015.
10. Times Live, 26 January 2015. Biologics' sickening cost. http://www.timeslive.co.za/thetimes/2015/01/26/biologics-sickening-cost. Accessed 16 March 2015.
11. Medicines Control Council of South Africa. Guidelines for similar biological medicines (biosimilar medicines) non-clinical and clinical requirements. Version 3. August 2014. http://www.mccza.com/documents/d259816c2.30_Biosimilars_Aug14_v3.pdf. Accessed 11 December 2015.
12. National Agency for Food and Drug Administration and Control (NAFDAC). Guidance document for the registration of biosimilars in Nigeria. December 2012. http://www.nlipw.com/guidance-document-for-the-registration-of-biosimilars-in-nigeria/. Accessed 16 March 2015.
13. Electronic Doctor, 29 September 2014. HMR 3rd Qtr14: Workshop Report – Biosimilars: Changing the pharmaceutical landscape and the way. http://www.edoc.co.za/modules.php?name=News&file=article&sid=5061. Accessed 16 March 2015.
14. African Institute of Biomedical Science & Technology. Biotechnology Forum. Regulatory insights in the development of biologics and biosimilars. http://www.aibst.com/index.php/component/content/article?id=52. Accessed 16 March 2015.