Biopharmaceuticals and Biosimilars

Since the development of the first biopharmaceutical, more than 200 approved drugs have entered the market that were developed through different biotechnological routes and licensed for several therapeutic goals. These biomolecules are divided into several classes, corresponding to half of the worldwide expenditures on drugs because of their extremely expensive production costs. The patents on some of these drugs are expiring or will expire within the next couple of years, which will lead to a race for the development of biosimilar molecules, denominated as second-generation drugs. Many countries are now developing or improving regulations for the approval and registration of new biopharmaceuticals and biosimilars, primarily by the Food and Drug Administration and/or European Medicines Agency. In this chapter, we present an overview of biopharmaceuticals and biosimilar products that are available worldwide, ranging from the first molecules released to the development of novel drugs entering the market.