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Welcome, Opening Remarks, and Keynote Address
Robin M. Weinick, PhD
- SVP/Managing Director Americas and Global Program Officer
- DIA, United States
Hillel P Cohen, PhD
- Executive Director, Scientific Affairs
- Sandoz Inc., United States
Ten years after the implementation of the Biologics Price Competition and Innovation (BCPI) Act, biosimilars are beginning to gain traction in the US. The leadership of FDA in establishing a pathway to demonstrate biosimilarity or interchangeability has been important in ensuring that these therapies can be made available to patients. Dr. Stein will share his perspective on the status of biosimilars in the US and important efforts that the Agency and other stakeholders can make to continue increasing access and acceptance of these therapies by patients and their healthcare providers.
Peter P. Stein, MD
- Director, Office of New Drugs, CDER
- FDA, United States