American Conference Institute is organizing the 4th Annual Biosimilars Conference in New York, USA on 6-7 June 2013.
ACI faculty will provide information on:
• Complying with the FDA standards on the abbreviated biosimilars pathway requirements;
• Meeting the heightened standard of interchangeability and outlining the parameters of similarity in the context of large complex biological compounds;
• Analyzing the complex patent resolution mechanisms outlined in the statute and proactively preparing for the intricate exchange process;
• Ascertaining the volume and level of safety data that will be required to prove patient safety and efficacy to facilitate approval;
• Determining the financial viability of biosimilars and exploring alternative pathways to approval including biobetters;
• The debate over naming and the new bills introduced restricting the ability of pharmacists to substitute generic versions of biological drugs for brand name products; and
• Investigating the impact of citizen’s petitions on the biosimilars market.
The website of the conference is: http://www.americanconference.com/biosimilars