FDA's Eva Temkin Discusses Biosimilar Approvals at ACI
In this article, The Center for Biosimilars recaps a keynote discussion between Kirkland partner Amanda Hollis and Eva Temkin, acting director for policy at the U.S. Food and Drug Administration's (FDA) Office of Therapeutic Biologics and Biosimilars (OTBB), at the American Conference Institute’s 11th Summit on Biosimilars & Innovator Biologics.
The article notes Ms. Hollis’ discussion of U.S. biosimilar applications, the coronavirus (COVID-19) pandemic’s impact on FDA priorities, and how the OTBB and FDA prioritize biosimilar projects.
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This article appeared in its entirety in the September 23, 2020, edition of The Center for Biosimilars.