The Biologics Price Competition and Innovation Act At 10–A Stocktaking

30 Pages Posted: 29 Jul 2020 Last revised: 6 Apr 2021

See all articles by Yaniv Heled

Yaniv Heled

Georgia State University College of Law

Date Written: July 1, 2020

Abstract

On March 23, 2010, President Obama signed into law the Biologics Price Competition and Innovation Act (BPCIA) as part of the Patient Protection and Affordable Care Act (a.k.a. “Obamacare”). The purpose of BPCIA was to create in biologics a regime similar to that of the Drug Price Competition and Patent Term Restoration Act (Hatch-Waxman Act) and, in so doing, to open biologics markets to competition and, subsequently, lower the price of these expensive and increasingly important pharmaceuticals. Using original data, this Essay takes stock of the decade that has passed since the enactment of BPCIA. The Essay surveys the state of competition in United States biologics markets, entry of follow-on biologics into these markets, and the effects such entry has had on biologics prices.

The Essay’s main findings are that, as of March 23, 2020—exactly ten years since the signing of BPCIA into law—the FDA has approved a total of 26 follow-on biologics deemed biosimilar to 9 original products (ratio: 2.63 follow-on/original products), with only 16 of these deemed biosimilar to 7 original products (ratio: 1.78 follow-on/original products) actually available on the market. None of these follow-on products has been approved as interchangeable with their reference products, which means that substitution of the 7 original products with one of their 16 approved biosimilars cannot be done automatically. The price of these products was 10-37% lower than the price of the original biologic, with the average price savings being 24% or 27%. All 35 approved follow-on and reference products are owned by a total of 11 pharmaceutical companies. The number of years of market exclusivity of the 9 original biologics before the approval of the first biosimilar ranged between 13.5-28.92 with an average of 18.27 years or 15.33-29.42 with an average of 19.87 years before the launch of the first competing biosimilar.

The Essay further puts forward a new method of measuring comparative levels of competition in drug markets by comparing the ratio of total approved follow-on products per total approved original products at certain critical benchmarks. Using this measurement tool, the Essay compares BPCIA’s track record with the levels of competition in small-molecule drugs before and after the Hatch-Waxman Act, showing that that BPCIA significantly underperforms in comparison and fails to instigate levels of competition that would lead to significant price drops and increase access to biologics in the United States. A short survey of the main likely reasons for BPCIA’s underperformance follows.

The Essay concludes by presenting the following question: if BPCIA’s current track record is (still) not enough to convince that it is failing to meet its goals, what more would it take to reach such a conclusion and how much longer should policymakers wait before it is possible to surmise that BPCIA in its current form has failed to significantly increase access to biologics in the United States.

Keywords: Biologics, biopharmaceuticals, pharmaceuticals, Food and Drug Administration, FDA, pricing, competition, Biologics Price Competition and Innovation Act, BPCIA, BPCI Act, follow-on, access to medicine, generics, biosimilars, interchangeables, interchangeability, biosimilarity, automatic substitution

Suggested Citation

Heled, Yaniv, The Biologics Price Competition and Innovation Act At 10–A Stocktaking (July 1, 2020). 7Texas A&M University Journal of Property Law 81 (2021), Georgia State University College of Law, Legal Studies Research Paper No. 2021-10, Available at SSRN: https://ssrn.com/abstract=3641860

Yaniv Heled (Contact Author)

Georgia State University College of Law ( email )

85 Park Pl NE
Atlanta, GA 30303
United States
404-413-9092 (Phone)

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