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As part of the “Consolidated Appropriations Act, 2021,” a COVID-19 relief and spending bill, 42 U.S.C. § 262(k) was amended to include new provisions for the FDA’s Database of Licensed Biological Products (“Purple Book”).  According to the new legislation, within 180 days of enactment, the FDA is required to update the Purple Book in a searchable, electronic format with new information, including:

  • A list of each biological product, by nonproprietary name, for which a biologics license is in effect or has been deemed to be a license;
  • The date of licensure and application number;
  • Licensure status and marketing status (as available); and
  • Exclusivity periods.

If a license is revoked or suspended for safety, purity, or potency reasons, it will not be published on the list, and the reference product sponsor must notify the FDA if this happens so it can be removed from the list.  The FDA is required to update the Purple Book every 30 days after it is first published.

Under the legislation, patent information will also now be listed in the Purple Book if the biosimilar manufacturer and reference product sponsor participate in the litigation provisions of the Biologics Price Competition and Innovation Act (BPCIA) (the “patent dance”) under 42 U.S.C. § 262(l).  Within 30 days of providing a list of patents (or a supplement to the list) to the biosimilar manufacturer under § 262(l)(3)(A), the reference product sponsor shall provide the patent list and expiration dates to the FDA for publication.  The amendment does not include a requirement for listing the patents should the biosimilar manufacturer and reference product sponsor choose not participate in the patent dance, and no consequences are given if the reference product sponsor fails to provide the list to the FDA.

Within three years after enactment, the FDA will solicit public comment on the information in the Purple Book to determine whether information should be added to or removed from it and will submit an evaluation to Congress.

Amendments in the “Consolidated Appropriations Act, 2021” affecting biosimilars can be found in Division BB, Title III, Subtitle C, Section 325, entitled “Biological Product Patent Transparency,” starting on pg. 4592 of the PDF available here.


    Methodology

    Information contained in the Venable Fitzpatrick BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website (www.fda.gov). Information relating to FDA licensed products, FDA-approved indications, and aBLA and 505(b)(2) applications is obtained from public sources including the U.S. FDA website (www.fda.gov). Information relating to litigations is given only for cases active from January 31, 2010 onward. Information relating to foreign biosimilar / biologics follow-on products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics graphics are compiled from information contained in the Venable Fitzpatrick BiologicsHQ database.

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