What Legal Issues are Presented by Biosimilars?

  • There are significant and unresolved legal issues implicated in the discussion of whether and how to approve follow-on biologics. First and most obvious is the lack of an established legal pathway for such approvals to be made by the Food and Drug Administration (FDA). Second, and equally important, there are serious questions about how FDA, in approving a follow-on biologic, could avoid unauthorized reliance on the innovator's protected trade secret and confidential commercial data and information. Such unauthorized reliance would violate not only section 505(b)(2) of the Food, Drug and Cosmetic Act (FDCA), but also the Trade Secrets Act and the United States Constitution.
  • Before FDA moves forward to implement a regulatory pathway for approving follow-on biologics, it is critical for Congress to debate and deliberate the issues and determine the necessity and feasibility of changing current law.
  • Unlike small molecule drugs, which are approved under the FDCA, most biologics are approved under the Public Health Service Act (PHSA). The FDCA provides a well-established legal framework for approving generic copies of small molecule drugs, but no commensurate legal framework is currently in place for approving follow-on biologics either under the FDCA or under the PHSA.
  • The use of section 505(b)(2) of the FDCA as a legal basis for FDA approval of follow-on products of those select biologics approved as drugs under the FDCA remains an untested and unresolved question of law. In fact, no product asserting a claim of "sameness" to a separate and distinct product has been approved by the FDA under 505(b)(2) to date.
  • The complexity of biologics makes it impossible to analyze them in a laboratory to the degree possible with chemical drugs, and to show without clinical trials that one biologic has the same safety and effectiveness profile as another.
  • In fact, the FDA for decades has correctly taken the position that each biologic is unique and inexorably linked to and inseparable from the manufacturing processes used in its creation. Complex operational and proprietary details of the manufacturing processes are central to and define the identity and unique molecular safety and effectiveness attributes of each biologic. Even if it were possible to establish "sameness" of biologics without clinical trials, agency reviewers would be unable to perform the rigorous scientific comparative assessment necessary to reach legitimate conclusions about "sameness" without first examining trade secret data concerning the manufacturing processes of the innovator, which is prohibited by law.
  • Therefore, the FDA could not safely approve a follow-on biologic based on findings about a competitor innovator product without relying - directly or indirectly - on trade secret and confidential commercial data and information, which has been provided to the FDA for the explicitly limited purpose of reviewing innovators' products and the specific processes used to make them.
  • Through its regulations and administrative practices, FDA has consistently protected the trade secret and confidential commercial data and information provided to it concerning biologics. These principles and practices have established the regulatory and legal foundation on which innovators have submitted marketing applications to FDA, and they should be preserved.