Abbvie Faces Competitor as a New Humira Biosimilar Comes to Market

On January 31, 2023, Amgen announced that its product AMJEVITA, a Humira biosimilar, is now available in the United States. This new availability threatens the stake that AbbVie has held for decades with its patent on Humira. For many years, Humira was one of the country’s best-selling prescription drugs, amounting to over $135 billion in sales across the US. Although the rollout and uptake of this Humira biosimilar will not be immediate, experts anticipate that it will significantly cut into AbbVie’s revenue.

"With today's announcement, AMJEVITA is the first US biosimilar to Humira, a medicine used by more than a million patients living with certain serious inflammatory diseases," said Murdo Gordon, executive vice president of Global Commercial Operations at Amgen, in the press release. "With our track record of developing and manufacturing biologics and decades of experience in inflammation, Amgen is uniquely equipped to supply this biosimilar medicine while reducing costs."

Privileged by US patent laws and market exclusivity, AbbVie made a large chunk of its annual revenue from the sale of Humira. When the initial patent for Humira expired in 2016 — the same year AMJEVITA was approved by the FDA — AbbVie applied for over 100 additional patents to keep control of the market, joining the roughly 70% of best-selling drugs that have had another patent or patent extension filed. Despite the fight by AbbVie to keep Humira biosimilars off the market, experts predict that many more will appear in the coming years.

AMJEVITA will be available in 40 mg doses with a 55% discount on the Humira list price for wholesale acquisition and 5% of the Humira list price for other purchases, significantly reducing healthcare spending as other existing biosimilars have done. Data from the Vizient 2022 Biosimilar Survey determined that biosimilars saved $12.6 billion between 2014 and 2022. As this Humira biosimilar and others come to market, many people estimate that saving will continue to expand.

“With biosimilars, when thinking about the promise of these agents, it is to bring competition, lower costs, and enhance accessibility and affordability of critical treatments,” said Sonia Oskouei, PharmD, Vice President of Biosimilars at Cardinal Health, in a 2022 interview with PharmaNewsIntelligence. “That is the core of what biosimilars are here to do. So that is a key strategy to help address some of these healthcare disparities and meet needs from various social determinants of health.”