The Manufacturing and Quality Assurance Process for Biologics and Biosimilars

Abstract

The rapidly growing market of biopharmaceuticals is opening new opportunities for biologics and biosimilar products especially in the vaccine therapeutics. As more and more products in this area are off the patents, the companies are looking to introduce biosimilar vaccines in the market. The challenges are enormous, and it is not easy to create a generic version of vaccine, as it was done for commonly used dosage forms like tablets, capsules, and so on. Biosimilar and biosimilarity are not synonymous, which means there are no clinically significant differences between the biological product and the standard product in terms of the safety, purity, and potency of the product. This chapter discusses the stepwise manufacturing and characterization of biosimilar vaccines, clinical studies, and safety and efficacy studies for such biosimilar vaccines. Biosimilar vaccine products and reference products are generated in the living cells and require trained expertise, as well as technology in manufacturing biosimilar products, which are usually highly effective compared to small-molecule drugs. The Food and Drug Administration (FDA)'s regulatory authority for the approval of biosimilar products is under Public Health Service Act; however, the approval of biosimilar products is also suggested to be regulated under the Federal Food, Drug, and Cosmetics Act (FD&C).