Title: Trends in Biologics and Biosimilar Development and Approval in the US
Speaker: Hae-Young Ahn, PhD, RAC, Deputy Division Director, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, Food and Drug Administration
Moderator: Chaitali Passey, PhD
Description: Therapeutic biologics often represent cutting-edge research in which the latest scientific discoveries are translated into novel therapies that provide new treatment options for patients. Biologic development and approval have been very active, and more than one third of new drugs approved by US FDA’s Center for Drug Evaluation and Research (CDER) are biologics in recent years. As of December, 2016, 123 biologic products have been approved, and clinical pharmacology studies play significant roles in biologic development and approval because of biologics’ unique characteristics. The Biologics Price Competition and Innovation Act (BPCI Act) created an abbreviated licensure pathway for biological products shown to be biosimilar to an FDA-licensed reference product. To implement the BPCI Act the Agency has published several guidance documents and the most recently finalized guidance is the Guidance for Industry – Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product. Clinical pharmacology studies are critical to developing the data needed to support a demonstration of biosimilarity as part of a totality of evidence framework.
After attending the webinar participants will be able to:
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- Be familiar with the current status of new biologic development
- Understand the differences between the goals of new biologic development and biosimilar development
- Be familiar with development strategies of biosimilar products in the US