The DIA 2018 Global Annual Meeting brings together thousands of innovators from around the globe.
Global Regulatory Strategies for Biosimilars
Oxana Iliach, PhD
Senior Director Regulatory Affairs, Biosimilars Center of Excellence
The number of approvals of biosimilars has increased significantly in both EU and USA over the last three years. However, for some originators there are still only a few biosimilar versions available and up until now there was no overall significant reduction in price in USA as compare to EU. Due to the complexity of biosimilar development, it is not surprising that the biggest and most advanced biotechnological companies remain the major players in the biosimilar field and on average it still takes up to 10 years to develop a biosimilar. Why is there reduced competition from smaller companies from emerging markets? Why do smaller companies seem to struggle when developing biosimilar products for the global market? What obstacles are preventing smaller companies from entering the EU and USA to help drive down the price of expensive originator biologics? The goal of this session is to explore these major questions using case studies of three biosimilars development of the same monoclonal antibody developed in emerging markets
Learning Objective : Discuss components of a successful regulatory strategy that can reduce biosimilar development time and get to market sooner; Identify common mistakes in biosimilar development that significantly increase time of overall development.
The Evolving Regulatory Guidelines for Biosimilars and Biologics
Addison Whitney, United States
Industry Perspective: Developing Biosimilars and Biologics in a Crowded Market
Yatika Kohli, PhD
Vice President, Regulatory Affairs
Medicago Inc, Canada
Health Canada Perspective
Agnes V. Klein, MD
Director, Evaluation of Radiopharmaceuticals and Biotherapeutic Products
Health Canada, Canada