US FDA consults on user fee program for biosimilar and interchangeable biologicals

The US Food and Drug Administration is requesting input from stakeholders and the public relating to the development of a user fee program for biosimilar and interchangeable biological product (351(k)) applications.

Biological products are produced in a living system such as a microorganism, plant, or animal cell, while small-molecule drugs are typically made through chemical synthesis. The degree to which follow-on biologics can be equivalent to their reference biologic counterparts is a question; thus, biosimilars and the developing approval process will likely be more complex than the approval pathway for generic versions of innovator pharmaceutical small-molecule products.

The Biologics Price Competition and Innovation Act of 2009, a provision of the Affordable Care Act, creates an abbreviated approval pathway for biological products that are demonstrated to be highly similar (biosimilar) to, or interchangeable with an FDA-licensed biological product. It directs the FDA to develop recommendations for a 351(k) user fee program for fiscal years 2013 through 2017. The recommendations must be presented to Congress by January 15, 2012.

Big savings expected through biosimilars access

The US Congressional Budget Office estimates that access to lower cost biosimilars - which would include expensive treatments for cancer, arthritis and rare genetic disordders - would save the nation around $25 billion over a decade.