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.

This audio conference covers:

• Descriptions of the relevant procedures, regulations and guidelines
• The regulatory experience to date relating to complex biosimilars
• Identification of the challenges concerning the demonstration of biosimilarity for such products
• Possible development plans for a complex biopharmaceutical
• Secrets of regulatory success

About the speaker:

Robert Blakie, Director & General Manager at ERA Consulting (UK) Ltd., has worked within the pharmaceutical industry for over 30 years. His regulatory experience is broad and global, covering new chemical entities (biopharmaceuticals and small molecules), devices, veterinary products, small molecule generics and biosimilar products. His therapeutic areas of expertise include oncology, cardiovascular, neurology, immunology, respiratory/pulmonary and anti-infectives.

Mr. Blakie has served on regulatory committees within industry associations such as the Bio Industry Association, European Generics Association and the Association of the British Pharmaceutical Industry. He received his BSc (Hons) Biological Sciences degree from the University of Leicester.

Who should attend?

• Regulatory Affairs Professionals
• Project & Business Development Managers
• Development Team Members
• Senior Management
• Pharma Industry Investors