is being presented by Ana T. Menendez, Senior Director, Biotechnology, Catalent Pharma Solutions and airs on Tuesday, August 10th, 2010. For more details or to register please visit our site at www.fxconferences.com
The FDA has recently provided a pathway to biosimilar development, which is expected to increase annual biosimilar revenues from $0.06 billion in 2008 to $1.95 billion by 2014 (Visiongain Report Biosimilars and Follow-on Biologics 2009-2024, 2009).
Biopharmaceuticals demonstrate therapeutic success because of their excellent targeting ability. This advantage is tempered with the danger of inducing an unwanted immune response in patients. Immunogenicity programs need to establish immunogenic similarity between innovator and biosimilar. Quick identification, characterization and interpretation of antibody response is crucial to interpret changes in the potency and safety of the drug.
The first part of this audio conference reviews intrinsic and external factors that can significantly impact immunogenicity risk management. The next two sections explain key documents (regulatory & industry), methods and timeline expectations to assure compliance. The last section discusses relevant case studies that highlight the impact of immunogenicity on the success of clinical trials.
