Is Pursuing Greater Biosimilar Competition a Worthwhile Goal?

August 31, 2019

Biosimilars Team

Encouraging increased competition in the biologics market with biosimilars remains the most promising mechanism to increase access to much-needed drugs, according to the authors of a Policy Forum article in the August 2019 issue of the AMA Journal of Ethics.

The article examines the current landscape of the biosimilar market, characterizes tactics employed by biologics manufacturers to delay market entry and deter prescribing of biosimilars, and assesses ethical issues related to increasing the adoption of biosimilars.

The authors cite two important reasons why biosimilars have not yet achieved policymakers’ intended goal of increasing competition and reducing prices. First, fewer than half all FDA-approved biosimilars have been marketed. Second, among biosimilars that have entered the market, price reductions have been limited and market penetration has been disappointing. Manufacturers of the originator biologic products have employed tactics such as ongoing patent litigation and formulary exclusivity to delay market entry of approved biosimilars and impede patient utilization. The limited availability of biosimilars has engendered skepticism among prescribers and users about the efficacy and safety of biosimilars.

The authors conclude that barriers to commercialization and uptake notwithstanding, biosimilars remain a powerful tool with potential to lower health care costs and improve patients’ access to valuable therapeutics.


Zhai MZ, Sarpatwari A, Kesselheim AS. AMA J Ethics. 2019;21(8):E668-678. doi: 10.1001/amajethics.2019.668.