AbbVie Plays Its Ace Cards Against Humira’s Decline

Nine biosimilars of Humira (adalimumab) launched in 2023, the first year that these biosimilars were able to compete with AbbVie’s originator product. A tenth, Simlandi (adalimumab-ryvk) was approved by the FDA in
February 2024.

Protected by its patent exclusivity, Humira was for years the top-selling drug in the United States. Sales reached $18.6 billion in 2022. A powerful anti-inflammatory medication and tumor necrosis factor-alpha blocker, Humira is approved as a treatment for patients with rheumatoid arthritis, Crohn’s disease and other autoimmune diseases characterized by dysregulated immune responses and inflammation.

Buffeted by biosimilar competition in 2023, Humira’s U.S. sales dropped by one-third, to $12.2 billion, a more than $6 billion slide. The company expects sales to decline further in 2024 as Humira’s biosimilar competitors gain further traction.

Amjevita’s head start

Oddly, the company that was considered to be in the best position to challenge Humira’s dominance did not capture market share that was anywhere near proportional to Humira’s sales decline. Amgen’s Amjevita (adalimumab-atto) hit the market at the end of January 2023, giving it a head start of at least six months on the eight other Humira biosimilar contenders that came on the market in 2023. Full-year U.S. sales of Amjevita amounted to just $126 million, Amgen reported in February 2024. In a statement to shareholders, Amgen explained that sales picked up in the fourth quarter of 2023, climbing 43% quarter over quarter, because of higher inventory and higher net selling price, “partly offset by volume decline.”

Amjevita doesn’t have the much-prized interchangeability designation that allows pharmacists to substitute a biosimilar for a reference product (state-level pharmacy laws may add qualifications to interchangeability). So far, three Humira biosimilars have the interchangeability designation: Alvotech and Teva's Simlandi, Pfizer’s Abrilada (adalimumab-afzb) and Boehringer Ingelheim’s Cyltezo (adalimumab-adbm).

Alvotech, an Icelandic company, is one of the ambitious companies in the now-crowded Humira market. The company trumpeted the news about its Humira biosimilar getting interchangeability status. But then it missed its intended launch date by more than six months when the FDA would not approve its factory setup in Reykjavik until changes were made.

Humira alternatives

The Humira biosimilar market is often depicted as an adalimumab-only cage match among Humira and its 10 biosimilars. However, much of that lost Humira revenue may be going to non-adalimumab drugs.

Two other agents AbbVie had in the wings were designed to pick up where Humira left off: Skyrizi (risankizumab-rzaa) and Rinvoq (upadacitinib), both of which are promoted as next-generation drugs that do much of what Humira does to quell inflammatory disorders.

Skyrizi’s U.S. sales climbed more than $2 billion in 2023 to $6.8 billion, and Rinvoq brought in $2.8 billion in sales revenue in the U.S., up from
$1.8 billion a year earlier.

Rick Gonzalez, CEO of AbbVie, who announced in February that he will retire in July, explained to shareholders that Skyrizi’s and Rinvoq’s climbing sales amid the rush of Humira biosimilars didn’t happen by accident.

“I think if you step back and you look over the last, I’d say, 10 years, we were trying to develop a strategy that we fundamentally believed would allow us to be able to offset the Humira loss of exclusivity and continue to deliver top-tier financial performance, as we have for the past 10 years,” Gonzalez said. “That was the whole objective, and we knew we had to build a very diversified growth platform in order to be able to do that— to be able to absorb that impact and return to growth as rapidly as possible.”