Biotherapeutics and Immunogenicity Implications in Drug Development

Immunogenicity

In contrast to new chemical entities, biotherapeutic drugs are potentially immunogenic, and, in rare cases, treatment with such products can lead to severe and devastating illnesses in humans. Therefore, the importance in understanding how immunogenicity affects drug exposure, efficacy, and toxicity at all stages of the drug development process can not be overstated.

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’s predicted that 50% of the top 100 drug sales will be biologics, an increase of 28% from 2008. Continue reading