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08 February 2021
The Consolidated Appropriations Act, which was enacted on 27 December 2020, requires drug manufacturers and licence holders to market biologic drugs and disclose all patents that cover their products to the Food and Drug Administration (FDA).
By increasing transparency, the act aims to force manufacturers to conform to rules which have proven successful in promoting the development and use of small-molecule generic drugs.
Thus, in addition to the list of Approved Drug Products with Therapeutic Equivalence Evaluations (the 'Orange Book'), which lists approved small-molecule generic drugs, the FDA will now maintain a Database of Licensed Biological Products (the 'Purple Book'), which will list approved biosimilar and interchangeable biological products.
In 2009 Congress enacted the Biologics Price Competition & Innovation Act (BPCIA) to provide an abbreviated pathway for biosimilars to gain FDA approval through the submission of an abbreviated biologics licence application. The goal was to reduce the price for biologics, as the Hatch-Waxman Act 1984 did for small-molecule drugs.
The BPCIA includes two main statutory provisions:
Within 180 days, the FDA will provide more information to the public in the Purple Book, including:
Reference product sponsors must provide patent information to the FDA within 30 days of the date on which the information is provided to the biosimilar applicant as part of the 'patent dance' for biosimilar approval.
The FDA will include this patent information when it revises the Purple Book every 30 days.
The FDA will publish any subsequent or supplemental list of patents provided to a biosimilar applicant.
There will be a request for public comment in 2023 regarding what should be added or deleted from the list.
For further information on this topic please contact Scott K Reed or Damineh Morsali at Venable LLP by telephone (+1 212 218 2236) or email (email@example.com or firstname.lastname@example.org). The Venable LLP website can be accessed at www.venable.com.
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