Monoclonal antibodies (mAbs or Moabs) are multiple identical copies of an antibody produced in the laboratory. Antibodies work as soldiers of the human body and attack foreign substances, including germs that cause diseases. Researchers can design antibodies that specifically target a certain antigen, such as one found on cancer cells and make copies of it. These monoclonal antibodies can, therefore, simply be considered as laboratory-produced versions of proteins that are designed to stimulate, enhance, and imitate the body’s defence system’s attack on disease-causing agents. They can bind directly to portions of viruses to prevent them from starting infections, and are usually given to a patient directly in an infusion.

AU Recommendation on Monoclonal Antibodies 

Monoclonal antibody products are rarely used in resource-constrained settings, and most African countries lack defined pathways for registering biologics and biosimilars. Africa CDC’s Research and Development lists them as priorities 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.

Regulatory Frameworks Across Countries in Africa

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[MW1] [U2] . 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 countries 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, a report by “Access to Medicines Foundation” found that 43 per cent of priority low- and middle-income countries, including 13 of 46 countries in sub-Saharan Africa have not registered innovative products, including mAbs and biosimilars. Only one 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 prohibitive 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 between US$5,712 and US$89,760, for a single patient’s annual therapy. Fewer than five per cent of breast cancer patients can afford it in the 14 African countries where it is available. In Kenya for instance, the cost of a single dose of Trastuzumab is more than 150,000 Kenyan shillings (almost US$1,400), while a 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 means that procurement and use of these therapies may only be possible through the private healthcare sector.

Examples of Application of Monoclonal Antibodies in the Health Sector in Africa
  • Monoclonal antibodies are used in many areas in healthcare, and more recently, they have been licensed in several countries for the treatment of COVID-19. 
  • Biochemistry, molecular biology, and medicine use monoclonal antibodies for diagnostic tests, and in analysing 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 and Zika viruses, as well as HIV. More recently, several countries have authorised the administration of monoclonal antibodies for the treatment of COVID-19 symptoms.
Policy Recommendations for Monoclonal Antibodies

To help guide the development and use of monoclonal antibodies (mAbs) in Africa, countries should:

  • Establish clear regulatory guidelines for the approval, registration, and monitoring of mAbs, biologics, and biosimilars in Africa. 
  • Build capacity within national drug regulatory authorities to evaluate the quality, safety, and efficacy of monoclonal antibodies. This includes training regulators in biotherapeutics and providing the necessary infrastructure for biosimilar testing and approval.
  • Collaborate with international research institutions to conduct trials and develop innovative mAbs treatments tailored to Africa’s health challenges.
  • Create policies that ensure that tested and approved mAbs for life-threatening diseases such as cancer, COVID-19, and autoimmune disorders are included in national essential medicine lists, making them eligible for public procurement and subsidised treatment.
  • Prioritise the inclusion of mAbs treatments in health insurance schemes to broaden access and reduce out-of-pocket expenses for patients.

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