By Donald Zuhn --
In April, Abbott Laboratories filed a Citizen Petition with the U.S. Food and Drug Administration, asking the agency to refrain from accepting biosimilar applications under the Biologics Price Competition and Innovation Act (BPCIA) that cite reference products (biologics) for which a biologics license application (BLA) was submitted to the FDA prior to March 23, 2010 (see "Abbott Asks FDA to Refuse Certain Biosimilar Applications"). The BPCIA, which provides an approval pathway for biosimilar biological products and constitutes a portion of the Patient Protection and Affordable Care Act that was signed into law on March 23, 2010, allows the FDA to accept biosimilar applications four years after a reference product has been licensed and to approve such applications twelve years after the reference product has been licensed.
In its Petition, Abbott specifically asked the FDA to:
[C]onfirm that it will not accept for filing, file, approve, or discuss with any company, or otherwise take any action indicating that the agency will consider, any application or any investigational new drug application (IND) for a biosimilar that cites, as its reference product, BLA 125057 for Humira® (adalimumab) or any other product for which the biologics license application (BLA) was submitted to FDA prior to March 23, 2010, the date on which the BPCIA was signed into law.
Abbott explained that the FDA should refuse biosimilar applications for all pre-enactment reference products, including its own biologic Humira®, because to approve such applications would constitute a taking under the Fifth Amendment of the U.S. Constitution, which requires just compensation. Noting that "[a]n innovator's resulting license application typically reflects more than a decade of research and contains analytical, preclinical, and clinical data, as well as detailed manufacturing information, most of which qualifies as trade secrets," Abbott contended that "[t]hese trade secrets are the private property of the reference product sponsor and are therefore protected by the Fifth Amendment to the U.S. Constitution." According to Abbott's Petition, "[w]hen FDA approves a biosimilar biological product on the grounds that the reference product has been shown safe, pure, and potent, it uses these trade secrets.
In a letter sent to Abbott's counsel on October 1, the FDA noted that it had "not yet resolved the issues raised in [Abbott's] citizen petition." The letter, which was sent by Jane Axelrad, Associate Director for Policy for the Center for Drug Evaluation and Research (CDER) at the FDA, states that the agency "has been unable to reach a decision on [Abbott's] petition because it raises complex issues requiring extensive review and analysis by Agency officials." The FDA's letter was provided in accordance with 21 C.F.R. 10.30(e)(2), which requires that the agency respond to a citizen petition within 180 days of receipt by approving the petition, denying the petition, or providing a "tentative response" indicating why the agency has been unable to reach a decision on the petition. The FDA's letter closes by noting that the agency will respond to the petition as soon as it reaches a decision on Abbott's request.
Additional information regarding the citizen petition can be found here.