FDA's Proposed Performance Goals for Biosimilar Applications May Provide Some Certainty for Biologics Companies

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The Food and Drug Administration (FDA) recently issued a Federal Register Notice in which it set forth its proposed FY 2013-2017 user fee and performance goals for biosimilar and interchangeable applications (§ 351(k) applications) under the Biologics Price Competition and Innovation Act (BPCIA). The Notice may remove some of the uncertainty facing biologics Reference Product Sponsors (RPSs) as to when a patent challenge might arise under the BPCIA, which sets forth the regulatory and patent litigation framework for biosimilar and interchangeable drug products.

The FDA's Proposed Performance Goals for reviewing § 351(k) Applications for FYs 2013 through 2017 recognized two distinct categories of applications: (1) those submitted 10 years or more after the date the reference product was first licensed, and (2) those submitted between 4 and 10 years after the date the reference product was first licensed. While Category 1 applications would be eligible for approval in 2 years or less, Category 2 applications would not be eligible for approval for more than 2 years and up to 8 years. Because of the long period of time before Category 2 applications could be approved, the FDA expressed concerns about allocating resources now to review those applications only to have to conduct supplemental reviews and inspections of facilities just prior to approval. Accordingly, the FDA proposed performance goals for reviewing only Category 1 applications and is seeking public comment, due by June 9, 2011, for establishing performance goals for Category 2 applications.

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