Five Republican U.S. senators have written to Health and Human Services (HHS) Secretary Sylvia Burwell to express concerns about the Food and Drug Administration’s (FDA) failure to date to issue guidance on the pathway to compliance for biosimilars, including “the key scientific policy questions related to biosimilars, such as naming, labeling, indication extrapolation, and interchangeability.”
According to Sen. Orrin Hatch (R-Utah), who, with Sen. Lamar Alexander (R-Tenn.), led their colleagues in calling on the administration to release biosimilar drug approval guidance documents, FDA has just accepted its first biosimilar application for review. They ask whether the agency intends “to approve the first biosimilar before policies on these key scientific questions are publicly released.” The letter indicates that FDA has forwarded the naming guidance to HHS, “and this guidance is awaiting HHS’ clearance so it can be released for stakeholder comment. . . . We urge you and those within your Department to immediately release guidance pending within the HHS related to the implementation of the biosimilar pathway.”
Meanwhile, FDA has announced the rates for biosimilar user fees for fiscal year 2015 (October 1, 2014, through September 30, 2015). The fee rate for initial biological product development (BPD) is $233,520; the annual BPD fee, assessed for the product each fiscal year until the sponsor submits a marketing application that is accepted for filing, or discontinues participation in FDA’s BPD program, is the same. The reactivation fee is nearly $500,000, and an application requiring clinical data is $2.33 million, while an application not requiring clinical data is $1.16 million. If the sponsor has submitted BPD and/ or reactivation fees, the application fee is reduced accordingly. See Sen. Orrin Hatch Press Release and Federal Register, August 1, 2014.
FDA has also issued draft guidance for industry titled “Reference Product Exclusivity for Biological Products Filed Under Section 351(a) of the PHS Act.” According to the agency, the document “is intended to assist sponsors developing biological products, sponsors holding biologics license applications (BLAs), and other interested parties in providing information and data that will help the Agency determine the date of first licensure for a reference product under 351(k)(7)(C) of the Public Health Service Act (PHS Act), as added by the Biologics Price Competition and Innovation Act of 2009 (BPCI Act). The BPCI Act amends the PHS Act and other statutes to create an abbreviated licensure pathway for biological products shown to be biosimilar to, or interchangeable with, an FDA-licensed biological reference product.” Comments are requested by October 6, 2014. See Federal Register, August 5, 2014.