Agreement Reached on Biosimilar Industry User Fees

In early February, Center for Drug Evaluation and Research Director Janet Woodcock testified to Congress that staffing at FDA needed to expand considerably to handle the the workload anticipated from the evaluation of biosimilar drug applications. The resources to pay for roughly double the FTEs from 2014 to 2015 should be derived from the Biosimilar User Fee Act (BsUFA), enacted in 2012. Under the law, FDA would collect its fees from industry but it would be expected to meet performance benchmarks, similar to the Prescription Drug User Fee Act for other drugs.

However, an agreement on what those actual fees should be has been in negotiation between the administration and industry trade associations since December 2015. Involved in the negotiations are Biotechnology Innovation Organization (BIO), Generic Pharmaceutical Association (GPhA) and the Biosimilars Forum, and Pharmaceutical Research and Manufacturers of America (PhRMA).Insulin Syringes

After 14 meetings between the sides, they finally reached agreement on a draft commitment letter at the end of June. This agreement will now be taken to the organizations’ members for their approval and published in the Federal Register for public comment.

The BsUFA is a 5-year agreement, and details of the draft are not yet available. Interestingly, one item at issue is whether FDA should have a separate group whose only function is to review biosimilar drugs.

For more information on these discussions, see the excellent article by Michael Mezher of the Regulatory Affairs Professional Society at

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