Biologics and Biosimilars

Biologics are pharmaceutical entities made from living organisms through highly complex manufacturing processes and need to be handled and administered under carefully monitored conditions. Since biologics and biosimilars are larger in size than chemical drugs, their manufacturing and purification processes can be more complicated and expensive compared to chemical drugs. Additionally, the cost of biological products is high because they require special handling and processing to avoid contaminations and are usually administered to patients via injection. These biological products include gene and cell therapies, therapeutic proteins, monoclonal antibodies, and vaccines used to prevent, treat, or cure various diseases, including cancer, chronic kidney disease, diabetes, cystic fibrosis, and autoimmune disorders. Once a biologic has been licensed by the U.S. Food and Drug Administration (FDA), a biosimilar may be developed. A biosimilar is a biological product that is highly similar to the biologic. A biologic and biosimilar are almost identical in terms of safety, purity, and potency, but may differ in clinically inactive components. Biosimilars, therefore, hold the potential to provide cheaper therapies involving large biological entities as their development process may be shorter. In this chapter, we discuss the different processes, techniques, and equipment involved to develop biologics and biosimilars.