Antibodies work as soldiers of the human body by attacking foreign substances including germs that cause diseases. Researchers can design antibodies that specifically target a certain antigen, such as one found on cancer cells. They can then make multiple identical copies of that antibody in the lab. These are known as monoclonal antibodies (mAbs or Moabs). Monoclonal antibodies can, therefore, simply be considered as laboratory-produced versions of proteins that are designed to stimulate, enhance, and imitate the body’s defense system’s attack on disease-causing agents. These medicines have the ability to bind directly to portions of viruses to prevent them from starting infections. They are usually given to a patient directly in an infusion.
Monoclonal antibody products are rarely used in resource-constrained settings, and most African countries lack defined pathways for registering biologics and biosimilars. They are listed in the Africa CDC’s Research and Development priorities as an area to be explored, under the list of drug and vaccine trials for Covid-19. Further, they are named in the list of strategic areas where the AU Health Commission’s Expert Panel on Africa’s COVID-19 Response Strategy are working. However, there are no specific guidelines or recommendations concerning them in other AU protocols.
Globally, the current regulatory guideline for monoclonal antibody technology is the WHO ‘Guidelines on the quality, safety and efficacy of biotherapeutic protein products prepared by recombinant DNA technology’. There are, however, several other guidelines which are also pertinent to mAbs for infectious diseases, including those espoused by the European Medicines Agency (EMA) and the United States Food and Drug Administration (USFDA). Many African countries do not have specific guidelines pertaining to mAbs use. Thus, very few mAbs have been licensed for use on the continent. Particularly, the lack of guidelines and variation in registration requirements and processes across Sub-Saharan African nations increases the cost, time and complexity for manufacturers interested in submitting their products for regulatory review, thereby making the Sub-Saharan African market unattractive for target by pharmaceutical companies. In fact, an ‘Access to Medicines Foundation’ report found that innovative products including mAbs and biosimilars are not even registered in 43 per cent of priority low- and middle-income countries, including 13 of 46 countries in Sub-Saharan Africa. Only 1 per cent of monoclonal antibodies including biosimilars are registered in Africa. For example, Nigeria has 10 registered and Zimbabwe has seven registered. In comparison, the USA, Canada and Europe together, account for 77 per cent of registered mAbs, with 112 mAbs registered in the USA and 77 in Brazil.
Further, for those that are available in Africa, the excessively high costs mean that African governments cannot afford to procure them for the public health sector. For instance, a highly effective mAbs treatment for breast cancer, trastuzumab, costs from US$5,712 to US$89,760, for a single patient’s annual therapy. This is an amount that fewer than 5 per cent of breast cancer patients in the 14 African countries where it is available can afford. In Kenya for instance, the cost of a single dose of trastuzamab translates to more than 150,000 Kenyan shillings (almost US$1,400), while its similar version costs about US$480 a dose, which is still too high for the average patient. For the Covid-19 mAbs treatment, estimates range from US$50 to $1,250 per dose, which is also prohibitively high for many in Africa. This leaves the private sector as the only way to procure the drugs, and only those that can afford them are able to access them.
Monoclonal antibodies are used in many areas in healthcare. Recently, its use in the treatment of COVID-19 has come to the forefront of global discussion. In biochemistry, molecular biology, and medicine, they have been used for diagnostic tests, and in analyzing and purifying their target compounds from mixtures. In clinical work, more than 100 mAbs have been licensed in the last 30 years globally and are being used to prevent and treat various diseases. These include for cancer treatment, autoimmune diseases such as Crohn’s disease, ulcerative colitis, ankylosing spondylitis, rheumatoid arthritis and in treating moderate-to-severe allergic asthma. There are currently monoclonal antibodies under development for preventive and therapeutic treatment of Ebola virus, Zika virus, HIV and more recently, the administration of monoclonal antibodies was authorized by several countries for the treatment of COVID-19 symptoms.
