FDA has at last began formal implementation of the Biologics Price Competition and Innovation Act of 2009 ("BPCI Act"), by announcing the proposal it will send to Congress to implement user fees for "generic" copies of biologics, called biosimilars in the BPCI Act. A biosimilar is a product approved under Section 351(k) of the Public Health Service Act ("PHSA"); approvals are not Federal Food, Drug and Cosmetic Act ("FFDCA") approvals. Under the proposal, the user fees for biosimilars - including the product application fee, the annual product fee and the annual establishment fee - would be identical to the fees established for human drug products approved under Section 505(b) of the FFDCA with one significant difference.

Because there are currently no biosimilars approved, FDA expects to expend significant resources upfront in evaluating research and protocols for biosimilar applications. As a result, it is proposing to assess a Biological Product Development ("BPD") Fee for review of Investigational New Applications ("INDs") submitted for biosimilar products. The fee would be due at the time of submission of an IND for a biosimilar product or, if requested, within five (5) days of FDA granting a request for a BPD meeting. In addition, a BPD fee would be assessed to any IND filed for a biosimilar product before any biosimilars user fee legislation is enacted. The BPD fee would be ten percent (10%) of the application fee established for a 505(b) application for the year submitted.