What is immunogenicity?
Immunogenicity occurs when our bodies treat a protein as if it is a foreign substance and try to attack the protein with antibodies. This is an important concern when it comes to the safety of biologics. Unlike chemical drugs, biologics have the potential to stimulate antibody production in patients. Human responses are highly unpredictable ranging from no effect to scenarios where the biologic binds and becomes inactive, resulting in disease progression. In other cases, they can bind to and inactivate a patient’s naturally occurring protein leaving the patient with no option other than regular blood transfusions.