SMi Conferences will be holding its inaugural "Biosimilars & Biobetters: Aligning Business & Science for Success" conference on September 22-23, 2010 in London. SMi faculty will discuss the latest developments in legislation, regulation, technology, and emerging commercial strategies in the highly competitive biosimilar market, including the following topics:
• Worldwide regulatory updates;
• The developing U.S. follow-on biologics framework;
• The challenges in biosimilar commercialization;
• Legal and IP developments;
• Biosimilar and biobetter monoclonal antibodies;
• Opportunities to drive a long term commercial strategy;
• Effectively leveraging licensing opportunities; and
• Biosimilar quality aspects.
In particular, SMi's faculty will offer presentations on the following topics:
• Biosimilars -- A global opportunity?
• Challenges in the commercialization of biosimilars;
• The developing biosimilars regulatory framework in the U.S.;
• EU guidelines and biosimilar development strategies;
• EU legal developments and strategies for biosimilar medicines;
• Biosimilars as a new business opportunity;
• Clinical comparability and European biosimilar regulations;
• Leveraging biosimilars licensing opportunities;
• Biosimilars in the clinic;
• EMA guidelines for biosimilar monoclonal antibodies;
• Developing "biosuperior" monoclonal antibodies;
• Biosimilar quality aspects;
• Biosimilar CMC development -- an innovator's point of view;
• Improving biosimilar delivery systems to compete with second-gen innovator products;
• Opportunities to drive your longer term biosimilars strategy; and
• Immunogenicity of biosimilars and biobetters.
workshop, entitled on "Biosimilars: Understanding the Regulatory Processes
and the Commercial Realities," will be offered on September 21, 2010. The workshop is intended to give
• A good overview of the biosimilars picture across the world;
• Insight into the varying regulatory approaches prevailing in different regions;
• An understanding of the commercial situation as it is now and likely to develop in the future; and
• Enough background to determine whether entering the biosimilars market is an appropriate strategy.
A complete brochure for this conference can be obtained here.
The registration fee is £1,399.00 ($2,126.46) for the conference and £599.00 ($910.47) for the workshop; alternative registration packages and discounts can be found on the conference website. Those interested in registering for the conference can do so here.
Patent Docs is a media partner of SMi's Biosimilars & Biobetters conference.