Drawing on the strength of SMi's successful Generics, Supergenerics and Patent Strategies conference series, we are proud to present our inaugural Biosimilars & Biobetters: Aligning Business & Science for Success.

According to a recent report published by Biophoenix, in 2009 the biosimilar-susceptible segment of the biologic market was worth US$63 billion and by 2013 biosimilars could generate a total market of $5.6 billion. The key driver to biosimilar development is the expiry of patents across the older leading biologics and with many of these products beginning to come off patent between 2015 and 2016 this industry is set to grow at a significant pace.

Biosimilars have attracted a great deal of interest recently and are seen by some as the new generic frontier. It is widely thought that lower levels of competition will lead to higher margins in an industry notorious for its generally low margins on commodity generics. Payer pressure is expected to drive uptake, particularly in the German, UK and US markets.

The EU has led the way in bringing biosimilars safely to market in establishing an approval process for biosimilars, with many biosimilars already marketed. Recent developments have seen the United States establish a long awaited abbreviated approval pathway for biosimilar  products and this will have major implications for both innovators and current biosimilar manufacturers.

Biosimilar manufacturers are also looking to strengthen their long term strategy, with many developing or acquiring technologies to produce improved biologics (or 'biobetters') to help compete against second generation innovator biologic drugs. Many believe that biobetters, with their improved characteristics are a more exciting and favourable proposition than biosimilars - will offer medical advantages along with a better price.

Hear experts in this field discuss the latest developments in legislation, regulation, technology and emerging commercial strategies to succeed in this highly competitive market.
 

Why not attend the associated pre-conference workshop as well?

Associated with the conference there will be a half-day interactive workshop on "Biosimilars: Understanding the Regulatory Processes and the Commercial Realities", taking place on 21st September.  It will cover overview of the Biosimilars picture across the world and provide insight into the regulatory and commercial situation, now and in the future. This will be led by Peter Wittner, Senior Consultant at Interpharm Consultancy.  To see more information about the workshop, please see the workshop page.

Keen to see the detailed programme?  Click here.

Want to download the brochure?  Click here.

Want to register your place? Click here.

Make a group booking - discounts apply

Worldwide regulatory updates The developing U.S. follow-on biologics framework The challenges in biosimilar commercialisation Legal and IP developments Biosimilar and biobetter monoclonal antibodies Opportunities to drive a long term commercial strategy Effectively leveraging licensing opportunities Biosimilar quality aspects       Rahul Padhye  Head, Corporate Development Reliance Life Sciences Huub Schellekens Professor, Department of Pharmaceutical Sciences & Innovation Studies Utrecht University   David Szymkowski Senior Director of Biotherapeutics Xencor  Huub Schellekens Professor Department of Pharmaceutical Sciences and Innovation Studies Utrecht University Matthias Hoepfner VP, Head GRA Global CMC & Change Management Bayer Schering Pharma See the full lineup...

 Members of Board, Vice President, Directors, Heads and Senior Managers involved in:

• Analytics
• Business Development
• Business Strategy
• Corporate Development Strategy
• Commercial Affairs
• Intellectual Property
• Marketing & Sales
• Medical Affairs
• New Product Development
• Legal Affairs
• Preclinical and Clinical Development
• Product Development
• Regulatory Affairs
• Pricing and Reimbursement
• Research and Development
• Quality Assurance
• Scientific Affairs
• Strategic Planning
• Strategic Sourcing
• Strategy

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Conference Documentation

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