As pointed out by Scrip, as part of the unveiling of the Obama administration's fiscal year 2011 budget, FDA officials outlined how the agency plans to prepare for an approval pathway for follow-on biologics (or biosimilars), despite a lag in US Congress moving to establish an explicit approval process. In total, the FDA seeks US$5.7 million next year to develop, among other items, a regulatory science behind biosimilars.

The problem is stalled healthcare reform legislation, as it remains unclear where Congress sits on creating a path for companies to apply for FDA approval of biosimilars. But according to the FDA's Director of Budget Formulation, MR Patrick McGarey, the agency will move forward and attempt to be fully prepared for when any legislation might be enacted. "We are working with Congress on legislation," he said on a conference call with reporters. "We are planning in advance and we are hoping that the administration's position on FOBs [follow-on biologics] will proceed." The FDA is asking Congress for US$2 million in funding for 2011 to help with research efforts preparing for a regulatory pathway for FOBs – and on top of that it hopes to roll over US$3.7 million from ‘carry over’ balances in unspent user fees toward the effort. That would result in a total of US$5.7 million to support agency activities as it prepares to develop FOB regulatory standards.

The goal is to prepare the agency from a scientific perspective, and hire scientists with the necessary expertise. "In this way we will have the resources in our budget to begin to launch FDA efforts," Mr McGarey said. "Regardless of the timing of the authorisation, we can still do the hiring; we can bring the experts on board so that they can do the science reviews that are necessary for [ensuring] safety and effectiveness of the products. It's anticipating so we are fully ready with any legislation that gets enacted to proceed with that new authority and avoid the passage of time that there might be if we had to wait for a budget event to catch up to it."

Mr McGarey said that he is aware of eight follow-on biologic products that have been approved by FDA. "Those all paid user fees under our existing drug user programme," he said. "So we'll just have to watch that process." He stressed that regulatory review of FOBs will not be done by the FDA's Office of Generic Drugs, and likely would be done by the Office of New Drugs.

References:

FDA News. Sebelius Highlights Inspections, Biosimilars in Congressional Testimony. FDA News Drug Daily Bulletin, Vol. 7 No. 26. 2010 February 8.

Nancy Faigen. US FDA prepares for biosimilars in 2011 budget plan, despite stalled reform bill. Scrip News. 2010 February 8.

Kathleen Sebelius, Health and Human Services Secretary: Department of Health and Human Services Fiscal Year 2011 Budget. Committee on Energy and Commerce. 2010 February 4