Strategic Immunogenicity Planning for Successful Biosimilar Development

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.

Achieving Global Registration of Complex Biosimilars

Similar biological medicinal products (biosimilars) became a reality in Europe when the CHMP adopted positive opinions for the two human growth hormones Omnitrope and Valtropin. Since then, more than ten marketing authorization applications for biosimilar products have been approved. However, there have also been failures. Currently, there are biosimilar products being developed for the more complex biopharmaceuticals such as monoclonal antibodies, and soon those will be submitted for registration.

This audio conference details the relevant regulatory procedures, regulations, guidelines and regulatory experience to date with complex biosimilars. The speaker identifies and discusses the challenges (CMC, non-clinical and clinical) concerning the demonstration of biosimilarity for complex biosimilars, and proposes possible global development plans.

Achieving Global Registration of Complex Biosimilars is being presented by Robert Blakie, Director & General Manager, with ERA Consulting (UK) Ltd. and airs on Thursday, February 25, 2010. For more details or to register, please visit our site at www.fxconferences.com