This paper explores the growth of biological medicine in the South African pharmaceutical sector for the period 2019 to 2023. The study analysis revenue trends over time and investigates challenges experienced and suggests possible solutions. Results show that small-molecules and biologicals follow a similar pattern with a major peak in 2021 and a decline thereafter, with total revenue for small molecules much higher than for biologicals over these years. Biologicals generally had growth through 2021, then experienced a significant decline in sales and growth in the following years. To promote the growth of biological medicines in South Africa, it is vital to streamline regulatory frameworks for quicker approval of biologicals and biosimilars while ensuring safety and efficacy. Implementing affordable pricing strategies and fostering collaboration between public entities, pharmaceutical companies, and insurers will enhance reimbursement policies. Additionally, increasing educational initiatives for healthcare providers will improve awareness and prescribing practices. Investing in local manufacturing can reduce costs and create jobs, while raising awareness of biosimilars as cost-effective alternatives will further boost their adoption and accessibility.
