ABSTRACT
Biopharmaceuticals, also known as biologics, differ significantly from traditional pharmaceuticals or small-molecule drugs, as they are produced using biological manufacturing processes rather than chemical synthesis. This category encompasses a wide range of medicinal products, including vaccines, blood components, gene therapies, somatic cells, tissue-based therapies, and recombinant therapeutic proteins. Introduced in the 1980s, biopharmaceuticals are created using biotechnological methods such as molecular biology, distinguishing them from biologics made through conventional biological techniques. These drugs aim to provide maximum therapeutic benefits with minimal risks. Biopharmaceuticals offer higher specificity, excellent activity, and reduced side effects compared to traditional drugs, making them effective in disease treatment, prevention, and diagnosis. The biopharmaceutical market is expanding globally, supported by significant investments and patents that protect innovations. Biosimilars are reshaping the industry by increasing competition, improving accessibility, and offering cost-effective treatment options. This chapter focuses on the development and commercialization of biopharmaceuticals, highlighting their benefits and growing significance in modern healthcare.
