It is widely acknowledged that South Africa needs its own biosimilar manufacturing industry, and in my view, there is no better time than the present. The technology required for their production and control has become standardised and the risks associated with the clinical use of these products, of which immunogenicity is the most important, are now better understood. The SAHPRA biosimilar guideline, which is being updated, coupled with the product-specific EMA guidelines, which we have adopted, and the knowledge base that have been built in the regulator over the past decade or so have resulted in an assessment approach by SAHPRA that promote the registration of these products. This is evidenced by the reduction in the data required for registration, such as nonclinical data which are no longer needed for safety assessment, extrapolation of data to other indications from a single clinical data set that shows comparability with the reference product in one indication, and more recently, the allowance for interchangeability with the reference product, without supporting data. It is envisaged that the requirement for a comparative clinical trial may soon be set aside as has happened in the UK. More biosimilars should translate into greater competition in the market, which would in turn make this important class of medicines more affordable and accessible to patients.
So what is holding up the establishment of the industry? Funding? Lack of a viable market? Regulatory barriers? Funding may be an issue, but it is by no means the most important as quite a few local start-ups had been established. The other two are not disincentives as there is an urgent public need for affordable biologics and regulatory requirements have been relaxed, as mentioned earlier. I believe that a major limitation is the shortage in this country of people with the technological expertise to actually manufacture a recombinant biological product at pilot and commercial scale. This was emphasised when I learnt of the difficulty a local company has to fill a position for a scientist with experience in protein expression and purification. Without competent people who have the right degree of technical confidence to work in a highly regulated and scientifically challenging GMP manufacturing environment, it will be impossible to develop a local biosimilar industry. In countries with a more developed biopharmaceutical industry, such experts will be trained within biopharma companies. Without a well-developed local biopharma industry, and almost zero prospects of foreign biopharma companies investing locally to enable technological transfer, how are we going to develop the required workforce?
To address this issue, South Africa could learn from Ireland’s experience with the growth in their biopharmaceutical industry just after 2010. Although it was spurred by multinational companies moving some of their manufacturing capacity to the country, Ireland faced a similar challenge – a lack of trained professionals in biomanufacturing. After extensive consultation within the industry and academia, the Irish government established the National Institute for Bioprocessing Research and Training (NIBRT) in Dublin in 2011 (https://www.nibrt.ie/). The institute provides broad training and education programs to several companies, including Merck, Amgen, J & J, Pfizer, Allergan and others. The NIBRT has a state-of-the-art pilot scale manufacturing plant with upstream, downstream, fill-finish, and complete process and product bio-analytical characterisation facilities. The Department of Trade, Industry and Competition has identified the pharmaceutical sector, which includes the production of vaccines and biological medicine, as having high growth and investment potential. Statistics South Africa has reported a high unemployment rate among the youth for the third quarter of 2022 with almost 3% being graduates and over 38% having matric. If a lack of trained bioprocessing engineers and scientists is a key limiting factor to the development of the biopharmaceutical industry in this country, then a concerted effort must be made by government, industry and academia to establish a similar institute to the NIBRT. It could be an important bridge between our educated but untrained youth and an employment-creating industry.