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Tuesday, June 26 • 8:00am - 9:15am
#212: Global Regulatory Strategies for Biosimilars

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Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Application UAN: 0286-0000-18-565-L04-P; CME 1.25; IACET 1.25; RN 1.25

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 Objectives

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.


Oxana Iliach, PhD


The Evolving Regulatory Guidelines for Biosimilars and Biologics
Brittany Scott

Industry Perspective: Developing Biosimilars and Biologics in a Crowded Market
Yatika Kohli, PhD, MBA

Health Canada Perspective
Agnes V. Klein, MD

avatar for Oxana Iliach

Oxana Iliach

Senior Director Regulatory Affairs, Biosimilars Center of Excellence, IQVIA
Oxana Iliach, PhD is a Sr. Director Regulatory Affairs at the Biosimilars Center of Excellence, IQVIA. She works with the team of dedicated professionals to develop and implement practical and creative strategies for biosimilars development from selection of target product to bringing... Read More →
avatar for Agnes Klein

Agnes Klein

Senior Medical Advisor, Health Canada
Agnes V. Klein MD is currently the Senior Medical Advisor in the Director General's Office, in the Biologics and Genetic Therapies Directorate. Dr. Klein trained in Endocrinology at UofT and has interests in multiple aspects of drug development and medical bioethics. Dr. Klein is... Read More →
avatar for Yatika Kohli

Yatika Kohli

Vice-President, Regulatory Affairs and Project Office, Medicago Inc
Dr. Yatika Kohli is a candid professional of strategic foresight & business acumen with over 15 years of experience in leading R2L activities in a fast-paced, high growth environment at global bio-pharma companies. She has expertise in developing global regulatory & clinical strategy... Read More →
avatar for Brittany Scott

Brittany Scott

Creative Director, Addison Whitney
As creative director, Brittany provides creative vision through innovative verbal and visual solutions. With more than 15 years experience, she has worked with a wide range of companies, specializing in pharmaceuticals. Prior to Addison Whitney, Brittany worked for Wells Fargo and... Read More →

Tuesday June 26, 2018 8:00am - 9:15am EDT
Room 204AB Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  09: Regulatory, Session