The Food and Drug Administration (FDA) announced a public meeting on 16th of December to discuss the proposed recommendations for a user fee program for biosimilar biological products for fiscal years (FYs) 2013 through 2017.
On March 23, 2010, President Obama signed into law the Affordable Care Act. The Affordable Care Act contains a subtitle called the Biologics Price Competition and Innovation Act of 2009 (BPCI Act) that amends the Public Health Service Act (PHS Act) and other statutes to create an abbreviated approval pathway for biological products shown to be biosimilar to or interchangeable with an FDA-licensed reference biological product. Section 351(k) of the PHS Act, added by the BPCI Act, allows a company to submit an application for licensure of a biosimilar or interchangeable biological product.
The BPCI Act also amends section 735 of the Federal Food, Drug, and Cosmetic Act to include 351(k) applications in the definition of “human drug application” for the purposes of the prescription drug user fee provisions. Accordingly, under section 736 of the Federal Food, Drug, and Cosmetic Act, the fee for a biologics license application (BLA) is currently the same regardless of whether the application is submitted under the new 351(k) approval pathway or the preexisting 351(a) approval pathway.
The BPCI Act directs FDA to develop recommendations for a biosimilars user fee program for FYs 2013 through 2017. The BPCI Act provides that FDA must consult with a range of groups, including scientific and academic experts, health care professionals, representatives of patient and consumer advocacy groups, and industry stakeholders, in developing the recommendations. FDA has already consulted with public and industry stakeholders from June 2011 through September 2011.
The BPCI Act requires that FDA must publish the recommendations for a biosimilars user fee program in the Federal Register and provide a period of 30 days for the public to provide written comments on the recommendations. FDA is also required to hold a meeting at which the public may present its views on such recommendations. After consideration of such public views and comments, FDA is to revise the recommendations as necessary and transmit them to Congress by January 15, 2012.
This notice, the 30-day comment period, and the public meeting will satisfy certain of these requirements. After the public meeting, FDA will revise the recommendations as necessary and present them to Congress.
As mentioned in the FDA release, four types of fees are proposed:
- Biosimilar product-development fees
- Marketing application fees
- Establishment fees
- Product fees