Biosimilars Industry Hopes For Jump-Start From User Fees

Law360, New York (July 17, 2012, 7:05 PM EDT) -- The new biosimilars user fee program, signed into law last week, focuses on funding early meetings between sponsors and U.S. Food and Drug Administration reviewers, meetings that experts say will be essential in getting U.S. biosimilars development off the ground.

The FDA has moved slowly in setting up the biosimilars pathway, which was created in 2010 as part of the Patient Protections and Affordable Care Act. The first official guidance was released in February but left major industry questions unanswered, and no biosimilars applications have yet...
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