A biologic medicine is a medicine whose active substance is derived from a biological source (i.e. a living organism)1 and include a wide range of products such as vaccines, blood and blood components, allergenics, somatic cells, gene therapies, tissues, and recombinant therapeutic proteins2. Biologic medicines form an essential part of modern medicine3 and have revolutionised the treatment of many disabling and life-threatening diseases1. They are highly specific and targeted therapies4, which generally have a larger and more complex molecular structure than chemically synthesised medicines1.
Due to their molecular complexity and the way they are manufactured, producing biological medicines tends to be more difficult than producing chemically derived medicines1. The biologic origin of these medicines also results in them possessing an inherent degree of minor structural variability, which is tightly controlled through manufacturing and quality processes to ensure consistent safety and efficacy1. A typical manufacturing process for a chemically synthesised medicine may involve 40-50 critical tests, whereas the manufacturing process for a biologic medicine may involve over 250 critical tests4.