Abbott Laboratories submitted a Citizen’s Petition to FDA, requesting that the agency not consider any applications for biosimilar versions of its monoclonal antibody therapeutic, Humira. Abbott’s legal team argues that the Biologic License Agreement (BLA) for Humira contains trade secrets, and even if FDA does not directly divulge any of those secrets to companies seeking to copy Humira, the agency cannot help but use those secrets when deciding whether a competitor’s application should be approved. Furthermore, they argue that the use of those trade secrets to advance a competitor would constitute a taking of Abbott’s property. The BLA for Humira was approved before the Biologics Price Competition and Innovation Act (BCPIA) was enacted, and Abbott argues that it submitted its BLA without any expectation that the contents would eventually be used to approve another company’s product. Therefore, no biologic approved before the enactment of the BCPIA should be the basis of a biosimilar approval.
Will this fly? It’s hard to imagine, given the precedents set by the generic drug approval pathway, and the reality of how FDA approves drugs. But it reads as a shot across the bow to those coming along behind with biosimilar versions of Abbott’s products. Be prepared to discuss the matter further in court.