House and Senate Committees Release Draft Bill that Reauthorizes the User Fee Program for Biosimilars

The House and Senate Committees released a draft bill on Friday to reauthorize user fee programs for biosimilars, pharmaceuticals, generic drugs, and medical devices from 2018 to 2022.  The bill states that the fees authorized by the amendments will be dedicated to, among other things, expediting the review process for these products.

In terms of its impact on biosimilars, the bill will establish, for the first time, an independent fee structure for biosimilars, including an “Initial Biosimilar Development Fee,” an “Annual Biosimilar Development Fee,” and an “Application Fee” for new biosimilar applications. A summary discussion published on April 14 clarified that the effective date is October 1, 2017, or the date of the bill’s enactment, whichever is later, but that the fee structure and amounts in the proposed bill applies to all biosimilar applications received on or after October 1, 2017, regardless of the date of the enactment.