Publication Date
7-28-2022
Abstract
Forty percent of spiraling drug costs in the United States stem from a mere 2% of all drugs—biologic drugs (biologics) made from living cells and administered by injection or infusion. Drug costs will continue to rise as new biologics are approved by the Food and Drug Administration. Biologics are expensive because they cannot be mass-produced, and the consequence of their high prices is that important treatments for conditions such as arthritis and cancer remain out of reach for many Americans. Fortunately, just as there are lower cost generic versions of brand-name pills, there are lower cost biosimilars of original biologics—the lower cost is made possible by an expedited regulatory approval process. Despite the lower cost and a decade of safe biosimilar use globally, U.S. adoption of biosimilars remains minimal, in stark contrast to widespread use of generic drugs. This Article provides the first comprehensive explanation of how U.S. laws, industry actions, and cognitive biases work together to impede the use of biosimilars in the United States. This Article argues that doctors and patients currently have unfounded misperceptions concerning the safety and efficacy of biosimilars based on misinformation propagated by companies that builds upon an existing cognitive bias against cheaper drugs. These misperceptions keep drug costs high and lead to worse health outcomes for patients—studies have shown that these unfounded misperceptions can have negative physical manifestations. Although there is a similar misperception against generic drugs, generic drugs do not face the structural barriers in regulatory laws and insurance coverage that exacerbate biases against biosimilars. For example, U.S. regulatory law requires an additional regulatory designation to permit a pharmacist to substitute a biosimilar without doctor intervention. No such additional regulatory designation is required for substituting generics. After revealing the existence and extent of the bias against biosimilars, this Article proposes solutions to effectively promote and increase biosimilar use. It suggests a multipronged approach to encourage biosimilar use, including legal changes to support biosimilar substitution, education to specifically tackle biases, and financial incentives to encourage biosimilar use. Addressing barriers to biosimilar use would not only expand access to treatment but would also save the United States an estimated $50 billion in the next decade.
First Page
517
Recommended Citation
Cynthia M. Ho, Biosimilar Bias: A Barrier to Addressing American Drug Costs, 99 DENV. L. REV. 517 (2022).