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.

A pre-conference
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
attendees:

• 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.