While FDA has made tangible progress in reviewing and approving applications for biosimilars, there are still significant barriers for sponsors attempting to access and succeed in the market. In this webinar, panelists will review the current roadblocks to a robust biosimilar market in the US, including regulatory approval challenges, patent litigation risks, and whether there is hesitancy to accept biosimilars as equivalent to their biologics counterparts by doctors, patients, and payers. Panelists will also discuss proposed and potential changes to the current system that could improve access to and use of biosimilars
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Eva Temkin, Associate Director for Policy (Acting), Office of Therapeutic Biologics and Biosimilars, CDER, FDA
Rachel Turow, Associate General Counsel, Regulatory Law & Policy, Teva Pharmaceuticals USA, Inc. and Member, FDLI Board of Directors
Michael Werner, Partner, Holland & Knight LLP
Moderated by John R. Manthei, Partner, Latham & Watkins LLP
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