The Parenteral Drug Association, Inc. (PDA) announced the participation of four confirmed officials from the U.S. FDA at its Biosimilars Conference, cosponsored with the Product Quality Research Institute, at the Hilton Baltimore, Baltimore, Md., June 20-21.Biosimilars entered the U.S. pharmaceutical market in 2015 with the U.S. FDA approval of Sandoz'sZarxio, a biosimilar of Amgen's Nuepogen. The U.S. Senate held hearings on biosimilars shortly after the approval.
The U.S. FDA will be represented at the PDA/PQRI Biosimilars Conference by the following confirmed officials:
- Steven Kozlowski, Supervisory Medical Officer, CDER
- Majorie Shapiro, Biologist, CDER
- Laurie Graham-Eure, Acting Director, Office of Policy for Pharmaceutical Quality, CDER
- Emanuela Lacana, Biologist, CDER
The conference will foster important discussion between industry experts and the U.S. FDA as they address possible solutions and new development strategies for biosimilars. Updates from the U.S. FDA will cover the challenges CMC reviewers face.
PDA is offering all regular registrants a free copy of its newly published book Pharmaceutical Legislation of the European Union, Japan, and the United States of America – An Overview, Second Edition.
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