Biosimilars: Regulatory Challenges and Barriers to Entry

Food and Drug Law Institute
March 18, 2021
2:00 PM - 3:30 PM ET

Healthcare & Life Sciences Partner Michael Werner will participate in a webinar discussion on the challenges of entering the biosimilars market in the United States. Although the U.S. Food and Drug Administration (FDA) has made some progress in reviewing and approving applications for biosimilars, regulatory challenges and litigation risks still pose significant barriers to accessing and succeeding in the market. Panelists will cover the FDA's approach to biosimilars, patent challenges and other legal questions, as well as discuss whether there is hesitancy to accept biosimilars in the medical industry. They will also describe changes that could create a more robust market and increase the use of biosimilars.

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