Publication Date

2024

Abstract

From COVID-19 vaccines to cancer treatments, biologic medicines are gaining importance in the U.S. health care system. Their high price tags, however, make these medications difficult for many Americans to afford. The Biosimilars Act, enacted in 2010, aimed to reduce costs and increase access to biologic medications by encouraging follow-on competition. The legislative effort followed in the footsteps of its predecessor, the Hatch-Waxman Act of 1984.

Although the Hatch-Waxman system succeeded in creating a landscape of more affordable and widely used generic drugs, the Biosimilars Act has failed to live up to its promise. Biologic drugs in the United States remain largely unaffordable, and no popular follow-on biologic market, akin to its non-biologic counterpart, has arisen.

Investigating the reasons behind these disappointing results requires an analysis of the inner workings of the Biosimilars Act, but such an analysis is difficult to find. In fact, the system set forth by the Biosimilars Act is so complex that scholarship has  argely avoided explaining it. To fill this gap in the literature and examine why the results of the Act have been so underwhelming, this Article explains the following: how the Biosimilars Act works in theory, how the parties are gaming the system, and why neither the theory nor the practice functions effectively. Through strategic tactics, biologic and biosimilar companies alike are ignoring and sidestepping the system.

The causes can be traced to the structure of the Act, itself. Specifically, by giving too much control to the parties involved, the Act enables them to work against society’s interests and the legislature’s goals. Although these misaligned incentives led to disappointing outcomes, the Article suggests that realigning the system does not require a major overhaul, but rather feasible tweaks. The changes recommended could expand the biologic market, create greater competition with cheaper alternatives, and spur affordable pricing for lifesaving biologic drugs.

Document Type

Article

Publication Title

Berkeley Technology Law Journal

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