Implications of Immunogenicity in Drug Development

Introduction Biotherapeutics emerged in the 1970s as viable alternatives to small molecule drugs when the advent of recombinant DNA technology allowed for cost-efficient, large-scale manufacture of proteins in cultured cells under controlled conditions. In 1982, recombinant human insulin, developed by Genentech and Eli Lilly, was the first biotechnology therapy to be approved by the FDA. Since then the biotechnology industry has reached more than 50 billion dollars in annual revenue, and continued growth is expected as pharmaceutical companies shift more resources into large molecule drug development, or make high-value acquisitions of biologics companies. There are more than 200 biotechnology products currently on the market with 400-plus additional therapies in clinical trials targeting diseases such as cancer, Alzheimer’s, rheumatoid arthritis, multiple sclerosis, and HIV/AIDS. In 2014, it is predicted that 50% of the top 100 drug sales will be biologics. This is a significant increase from 28% in 2008 and 11% in 2000 [EvaluatePharma 2009].