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
