Biosimilars in the US

January 6, 2011

Applied Clinical Trials

Biosimilars in the US

The Food and Drug Administration recently held a two-day public hearing as it prepares to put into place regulations for the approval of generic versions of biological products. PharmaNet Consulting executives, William M. Egan, PhD, Vice President, and Jeffrey J. Freitag, MD, Senior Vice President, provide an overview of the meeting; the current market temperature of biologic development programs in the US; and what sponsors can expect in lieu of a formal FDA guideline.

Jeffrey J. Freitag, MD, Senior Vice President

William M. Egan, PhD, Vice President

 

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