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