ABSTRACT
INTRODUCTION The development of biologic therapies has been a major biomedical advancement in recent times. With the development of recombinant DNA technology, the large-scale production of human homologues such as the interferons (IFNs), growth factors (e.g., Epogen), and hormones (e.g., insulin) became feasible. More recently, other types of biologic therapeutics, such as monoclonal antibodies and engineered fusion proteins, have been developed and used in the clinic. The United States sales of biologic therapeutics amounted to $40.3 billion in 2006, with several biologics reaching the status of “blockbuster” with more than $1 billion in sales (1). There are more than 160 biologic therapeutics available today (2), and more than 370 new biologics are currently in various stages of clinical testing. Biologic therapeutics are being used in the clinic for a wide range of disorders, including cancer and rheumatoid arthritis, psoriasis, anemia, hepatitis C, muscular dystrophy, and diabetes.
