Why Are Biosimilars Not Living up to Their Promise in the US?

Biologics are among the most expensive prescription drugs in the United States, posing significant barriers to patient access to necessary treatments.An abbreviated approval pathway for biosimilars, nearidentical versions of biologics made by different manufacturers, was created by Congress in 2010 to stimulate competition in hopes of driving down costs and expanding access.However, as of February 2019, only 17 biosimilars have been approved, with only 7 currently on the market.Of the few biosimilars currently available to patients, overall utilization has been limited.This 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.Expensive Biologics Biologic drugs, which include therapeutic proteins and monoclonal antibodies, are large complex molecules typically manufactured in genetically engineered organisms, such as modified bacteria.1 Biologics can be remarkably effective in treating a variety of illnesses, ranging from autoimmune diseases to cancer, but their high prices-often in excess of $100 000 per patient per year-have driven persistent growth in prescription drug spending.1 In the United States, biologics account for 38% to 40% of all pharmaceutical spending, 2,3 but fewer than 2% of Americans use them. 2 From 2010 to 2015, biologics represented 70% of the growth in US drug spending.2,3 One proposed solution to address the high cost of biologics was to facilitate the introduction of competitor products (called biosimilars) that are nearly identical to older, off-patent biologics via an abbreviated approval pathway.A similar pathway for generic small-molecule drugs had been created by the 1984 Hatch-Waxman Act 4 and proved successful.Generic drugs now account for about 90% of all dispensed prescriptions in the United States and have saved the health care system roughly 1 trillion dollars between 2002 and 2011.5,6 Accordingly, in 2010, Congress passed the Biologics Price Competition and Innovation Act (BPCIA), modeled loosely on the Hatch-Waxman Act, as part of the Affordable Care Act, thereby establishing an abbreviated pathway for biosimilars to gain