AbbVie Hopes to Maintain Humira Exclusivity Through Secondary Patents and Regulatory Barriers to Entry

In terms of revenue, AbbVie’s Humira was not only the best-selling biologic in 2014, it was the best-selling drug worldwide, with global sales of $13 billion. The success of Humira has motivated other biopharmaceutical companies to develop their own biosimilar versions of the biologic, but AbbVie is not going to surrender Humira market share without a fight. This Report surveys some of the recent regulatory and patent developments in this ongoing struggle between AbbVie and its would-be biosimilar competitors, including: (1) challenges to AbbVie’s secondary patent estate in the U.S. and Europe; (2) AbbVie’s citizen petition asking FDA not to implement the Biologics Price Competition and Innovation Act of 2009 (BPCIA) as to any application for a biosimilar product that cites as its reference product for which the BLA was submitted to FDA prior to the enactment of the BPCIA, which would include Humira; (3) AbbVie’s petition requesting that FDA require the labeling of biosimilar products licensed under the BPCIA to include a clear statement that the product is a biosimilar, that the biosimilar is licensed for fewer than all of the reference product's conditions of use (if applicable), that the biosimilar' s licensed conditions of use were based on extrapolation (if applicable), and a clear statement that FDA has not determined that the biosimilar product is interchangeable with the reference product (if applicable); and (4) AbbVie’s petition asking FDA to require applicants seeking a determination of interchangeability to meet the statutory safety standards for determining interchangeability with respect to each condition of use for which the reference product is licensed.