Magazine Article | October 29, 2014

The Biosimilars Opportunity: 4 Years Of Waiting

Source: Life Science Leader

Biosimilars have been approvable in the U.S. since the 2010 passage of biosimilars-enabling legislation. However, no product applications have been approved. A few have been filed, but the industry largely remains on hold as the FDA waits to release needed guidance. Now, even the U.S. Senate is pushing the FDA to release guidance documents on biosimilar drug approvals.