The SMi Group will be holding its 2nd conference on Biosimilars and Biobetters from September 26-27, 2011 in London, UK. The conference will offer presentations on the following topics:
• The market for biosimilars: Unraveling the mystery;
• The EMA scientific advice compared with EMA guidelines;
• Industry interpretation the new guideline on biosimilar mAbs;
• Next generation monoclonal antibody development and clinical challenges with biosimilar drug development;
• EU litigation considerations and update;
• The ins and outs of the biosimilar regulatory pathway;
• The developing biosimilars regulatory framework in the U.S.;
• U.S. patent issues in biosimilars;
• Biosimilars: Patent protection issues;
• Maintaining a consistent quality standard of biosimilars;
• From imitation to innovation -- Biosimilars are not generics;
• Making things last longer for less;
• Pharmacovigilance & biosimilar monoclonal antibodies: Practical considerations;
• Factors to be considered for biosimilar CMC development;
• GCSF biosimilar case study;
• Biosimilar sales forecast in seven unregulated markets in 2016: How large is the opportunity?
• Opportunities to drive your longer term biosimilars strategy -- India and emerging market perspective.
Two post-conference workshops will be offered on September 28, 2011. The first workshop, entitled "How similar is similar?" will cover a variety of factors that dictate and determine exactly how similar is similar. The second workshop, entitled " A Global View of Biosimilars: Regulatory Analysis and Pricing Structure Case Studies," will examine the potential of companies with a strong biosimilars portfolio in emerging markets to expand into highly-regulated markets via alliances, M&A deals and utilization of post-marketing data.
The programme for the Biosimilars and Biobetters conference can be found here (Day 1), here (Day 2), and here (workshops). A complete brochure for this conference can be obtained here.
The registration fee for the conference is £1,399 and for each workshop is £599. Those registering for the conference by July 15, 2011 will receive a £200 discount. Those interested in registering for the conference and workshops can do so here.
Patent Docs is a supporting publication of the Biosimilars and Biobetters conference.
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