On September 12, FDA's Center for Drug Evaluation and Research ("CDER") Director Janet Woodcock, M.D. reported FDA's biosimilars program will be "under-resourced" until the biosimilars industry develops at a Drug Information Association ("DIA")/FDA Biosimilars Conference: Guidances, Science, and BsUFA. "This is going to be an under-resourced program for the next few years because that's how it is ... That'll cause, I think, some struggle, especially with allocation of resources amongst all the important activities that we do at FDA," Woodcock said. (The Pink Sheet, September 12, 2012.)
Once again, FDA reported that while FDA has the authority to approve biosimilars, FDA still has yet to receive a single biosimilars application, called 351(k) applications, based on their new statutory provision. FDA reported the same numbers that were discussed in two recent conferences discussing biosimilars that we reported on here and here: 11 investigational new drug applications ("INDs") and 30 pre-IND meetings with the Agency concerning biosimilars. FDA recently did approve Teva's biosimilar version of Amgen, Inc.'s Neupogen® (filgrastim), but Teva submitted this as a full biologics license application ("BLA") rather than a biosimilar, because reportedly Teva believed the biosimilar pathway was either infeasible or not ready for commercial approvals yet.
Woodcock speculated that annual product fee payments for sponsors with INDs will likely be the initial source of extra funding that FDA receives, with 351(k) fees to follow only after sponsors start submitting these applications. Under the Biosimilars User Fee Act ("BsUFA") that will become effective on October 1, 2012 along with other user fees, barring any possible derailment, which we reported here, the development fees are only 10% of the marketing application fees for each year, but the payments will be subtracted from the marketing application fee, once filed. For example, in Fiscal Year 2013, the product development fee for a 351(k) application is $195,880 with 351(k) application fees set at about $1.96 million per application.