Biologic medicines represent some of the most significant—both clinically and financially— pharmaceutical products in the United States today. Biologics have had remarkable success in the treatment of patients with many common diseases and disorders such as cancer, diabetes, multiple sclerosis, arthritis, and anemia. However, biologics remain one of the most expensive categories of medicines on the market. According to the Federal Trade Commission (“FTC”), the cost of one year of treatment of a biologic medicine can range from $50,000 to $250,000.

Biologics’ active drug substances are cultivated from living organisms by means of recombinant DNA or controlled gene expression methods. Biologics include a wide range of products such as vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and recombinant therapeutic proteins. Biologics are “typically larger and more structurally complex molecules” than the traditional small molecule drugs. Therefore, production of biologics requires more difficult and expensive manufacturing processes and techniques to ensure consistency.