Another attempt at a collaboration on a pathway for biosimilars is under way by Congress, the administration and the FDA, after several premature efforts. Two years ago, when the first biosimilar was approved for sale in the EU, fundamental questions arose. Biosimilars in the U.S. are bound to face even more scrutiny.
In a new BioWorld Today audio conference, Linda Horton, an FDA veteran and expert on EMEA policy, will provide insight on the EU biosimilars pathway and lessons learned over the past two years. She also will describe the current U.S. legislation and inevitable changes.
"Biosimilars in the U.S.: What the Approval Process Could Look Like and What We've Learned from the EU" is just $349 per listening site. Scheduled for April 17th, 1-2:30 p.m., E.T., it includes handouts and a half-hour Q&A session. A conference CD (MP3 format) is available. For information or to register, call 800-688-2421 or 404-262-5474, and mention conference code T08490.