C5Group, is organizing the 3rd C5 Forum on Biosimilars in London, UK on 5 December, 2013.
Hear industry experts share their experience on the key regulatory, development and legal barriers that have to be overcome throughout the entire life cycle of a successful launch, including:
• Navigating the European regulatory landscape for biosimilar approval: what biosimilar producers need to know in order to obtain approval of their products
• Deciphering the EMA guidelines on monoclonal antibodies to access the lucrative mAb market
• Updating your CMC strategies in line with evolving global Biosimilar regulations and current market trends
• Practical claims drafting and patent prosecution strategies for Biosimilars and Innovators
• What defence strategies are originators utilising to curtail biosimilar competition
• Harmonising your Biosimilar development programme to obtain regulatory approval in Europe and America
• Establishing a best approach to your pricing and reimbursement strategies in order to achieve successful market access
• How successful biosimilar manufacturers have been in initiating discussion with the medical community and promoting the uptake of biosimilars
For more information or to register for the event, please check c5-online.com.