The Biosimilar Action Plan: An Effective Mechanism for Balancing Biologic Innovation and Competition in the United States?

42 Pages Posted: 20 Nov 2019 Last revised: 6 Oct 2020

See all articles by Simone A. Rose

Simone A. Rose

Wake Forest University School of Law

Tracea Rice

Fish & Richardson P.C.

Date Written: November 18, 2019

Abstract

The strain between balancing pharmaceutical innovation and competition in the United States (U.S.) is centered around the need to ensure that the U.S. continues to encourage medical innovation while simultaneously providing patients with access to affordable and innovative drug treatments. This tension exists whether the drugs at issue are chemically-synthesized or complex large molecule drugs, such as biologics. In 2010, Congress passed the Biologic Price Competition and Innovation Act (BPCIA). The statute created a statutory approval pathway for biological products shown to be biologically similar (biosimilar) to the originator or “brand” biologic, while retaining the same safety, purity, and potency as the brand. Unfortunately, the BPCIA’s provisions failed to accelerate biosimilar product development in the United States and we continue to lag behind Europe in providing patient access to affordable biosimilars.

To help stimulate the U.S. biosimilar market, the Food and Drug Administration (FDA) issued the Biosimilar Action Plan (BAP) in July 2018. BAP focuses on four key strategies: 1) streamlining the biosimilar approval and product development process; 2) increasing biosimilar informational resources; 3) maximizing scientific and regulatory clarity; and 4) “getting competitively priced biosimilars into the market by reducing the gaming of FDA requirements and other attempts to unfairly delay competition.”

An enhanced informational platform and streamlined approval process should increase the biosimilar approval rate and accelerate biosimilar product development. However, the FDA’s regulatory powers are insufficient to curb the gaming and other anticompetitive behaviors that most negatively impact access, such as: 1) rebating schemes; 2) pay-for-delay agreements; 3) leveraging innovator patent rights to impede biosimilar market entry and 4) other regulatory abuses. Partnerships with key stakeholders, such as Congress, the Federal Trade Commission, States, Non-Governmental Organizations, and Payors are therefore crucial to achieving the BAP’s overarching goal of “promoting competition and affordability [of biosimilars] across the market.” The recently proposed Biologic Patent Transparency Act provides an example of how Congress can work in tandem with the FDA and other stakeholders to foster innovation and build a competitive and sustainable biosimilar marketplace for patients in the U.S.

Keywords: pharmaceutical innovation and competition, Biologic Price Competition and Innovation Act (BPCIA), BPCIA, Biosimilar Action Plan (BAP), BAP

Suggested Citation

Rose, Simone A. and Rice, Tracea, The Biosimilar Action Plan: An Effective Mechanism for Balancing Biologic Innovation and Competition in the United States? (November 18, 2019). McGeorge Law Review, Forthcoming, Wake Forest Univ. Legal Studies Paper, Available at SSRN: https://ssrn.com/abstract=3489444 or http://dx.doi.org/10.2139/ssrn.3489444

Simone A. Rose (Contact Author)

Wake Forest University School of Law ( email )

P.O. Box 7206
Winston-Salem, NC 27109
United States
(336) 758-4496 (Phone)

Tracea Rice

Fish & Richardson P.C. ( email )

1717 Main St.
Suite 5000
Dallas, TX 75201
United States

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