The Future of Biosimilars in the US: Legal, Regulatory, Scientific, Regulatory, Clinical and Payer I
|Event Date/Time: May 04, 2011||End Date/Time: May 05, 2011|
Some of the questions to be addressed include:
â€¢ What level of similarity and extent of physio-chemical and biological data will be required to demonstrate the follow-on protein to be â€œhighly similarâ€ to the innovator product and to qualify as a biosimilar?
â€¢ What is the value of non-clinical testing for the demonstration of â€œbiosimilarityâ€?
â€¢ How extensive should clinical testing be?
â€¢ To what extent can one extrapolate findings from one population to other populations based on the originatorâ€™s data?
â€¢ What criteria must be fulfilled to achieve interchangeability status?
â€¢ How does exclusivity operate under the BPCIA? Is it market or data exclusivity?
â€¢ When can supplemental applications qualify for exclusivity?
â€¢ What are the implications for intellectual property protection and litigation?
â€¢ What labelling and nomenclature need to be applied to biosimilars?
â€¢ What will be the impact on patient access to expensive biological medicines and to what extent will patient choice become compromised or even severely limited?