STATEMENT: Cost savings imminent for millions of patients who need Humira

For Immediate Release: Monday, Jan. 30, 2023

Expensive, commonly prescribed drug finally faces biosimilar competitor after patent extensions expire

WASHINGTON – The world’s best-selling drug behind COVID-19 vaccines, Humira, will face its first competitor on the U.S. market this week when a biosimilar competitor finally is allowed on U.S. pharmacy shelves. Humira’s primary patents ended in 2016 but AbbVie, the maker of the rheumatoid arthritis medicine, has successfully kept competition at bay. AbbVie applied for 312 patents for Humira, 166 of which the U.S. Patent and Trademark Office granted. These patents have successfully extended the life of AbbVie’s brand ownership of Humira, which in 2021 brought in $17.3 billion in U.S. sales. Patients in Europe,  where the drug’s price is 80% lower, have benefited from competition from biosimilars. 

Amjevita, sold by Amgen, is expected to launch on January 31, 2023, becoming the first biosimilar to compete with Humira. Six other biosimilars could be on the market by the end of the summer. Biosimilar competition is expected to dramatically impact prices. The U.S. Food and Drug Administration (FDA) reports that when just one additional drug competes with a brand name, prices decrease by as much as 40%. When crucial medications can cost tens of thousands of dollars a year — or even more —  that’s significant savings for patients, health plans and federal programs such as Medicare. 

In reaction to the pending expiration of Humira patent protection, U.S. PIRG’s Senior Director of Health Care Campaigns Patricia Kelmar, issued the following statement: 

“Patients and payers have been waiting an extra seven years for Humira to come off patent and allow biosimilars to compete on price. More than two years ago, we joined a legal challenge to put an end to AbbVie’s anticompetitive tactics which have kept biosimilars off of the U.S market. The U.S. price has been absurd given that patients in Europe could get this medication at a fraction of that price.

“We’re glad the long wait is over, but the delay has cost patients, taxpayers and insurance companies billions. We need to put a stop to this practice of abusing the patent system. It has become an all-too-common corporate strategy to keep biosimilars and generic drugs from patients. It’s time the pharmaceutical industry focused its brain power on finding new cures and treatments, not just tricky ways to extend the patent life of a drug that has been around for more than 20 years.”