Overview

March 23, 2020 marked the Biologics Price Competition and Innovation Act transition date, on which nearly 100 drugs previously approved as new drugs under Food, Drug, and Cosmetic Act section 505 transitioned to approved biologics licenses under section 351 of the Public Health Service Act. What are some of the lingering issues associated with the transition and future approval pathways for these drugs and related biosimilar/interchangeable products? The webinar will address transition questions about chemistry, manufacturing, and control requirements; as well as labeling, exclusivity, compounding, and 505(b)(2) applications. The webinar will also discuss regulatory pathways and potential pricing implications for transitioned products and related biosimilar/interchangeable biologic candidates.

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Speakers

David V. Ceryak, Senior Director, Assistant General Counsel, Regulatory Legal Team, Eli Lilly and Company
Lee Rosebush, Partner, BakerHostetler
Moderated by Catherine M. Cook, Executive Vice President, Drug and Biological Products,  Greenleaf Health, Inc.

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