As Humira's biosimilar reckoning looms, AbbVie pads case for immunology successor Rinvoq

AbbVie is piling up indications on its latest drugs to help cushion Humira’s fall as the immunology cash cow inches ever closer toward its patent cliff, with biosimilar competition expected to start in January 2023.

Late last week, the company said Rinvoq had nabbed its sixth FDA nod, this time in adults with active non-radiographic axial spondyloarthritis (nr-axSpA). The approval specifically covers patients with objective signs of inflammation who’ve either failed on or weren’t suitable for tumor necrosis factor (TNF) blockers like Humira, AbbVie said in a release.

The additional green light comes shortly after Rinvoq’s April OK to treat adults with ankylosing spondylitis (AS) with similar TNF blocker problems. The nr-axSPA FDA go-ahead makes AbbVie’s JAK inhibitor the first and only member of its class approved in both conditions.

AbbVie has pinned big hopes on Rinvoq and its sibling Skyrizi, which the company previously predicted could hit combined sales of more than $15 billion by the middle of the decade. Still, that won't entirely make up for losses from Humira, which brought in $20.7 billion in 2021 sales and is the world’s all-time best-selling drug, having made $200 billion over the course of some 20 years. With exclusivity losses coming up early next year, AbbVie is trying to get the lay of the land as nearly a dozen generic Humira competitors line up.

Rinvoq’s latest approval tees up an entry in Nr-axSpA—a chronic, progressive inflammatory rheumatic disease that causes joint pain and leads to back pain and stiffness. Both nr-axSpA and AS are sub-types of a broader condition called axial spondyloarthritis.

“Approximately five percent of patients with nr-axSpA will progress to AS after five years and 19 percent will progress after 10 years,” the company said in its release announcing the nr-axSpA nod.

The FDA’s approval leveraged data from AbbVie’s phase 3 Select-Axis 2 trial. At the trial’s 14-week mark, nearly half of patients on 15mg Rinvoq achieved improvements necessary to trigger a response on a composite index of disease activity versus placebo, allowing the study to meet its primary endpoint. Safety was on par with Rinvoq’s known profile in rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis, AbbVie added at the time.

Patients in the study who received Rinvoq also charted a “significantly” greater mean reduction from baseline in total back pain compared to placebo, as well as a significantly greater improvement in physical function from baseline.

Back on the Humira front, Amgen is the first company that will get a crack at competing with its biosimilar Amjevita, which is due to launch in January 2023. It will be followed by the likes of Coherus, Fresenius KAbi, Pfizer, Samsung Bioepis, Sandoz and Viatris.

In its last second quarter of market exclusivity, Humira pulled down $4.66 billion in the U.S., climbing 9% year-over-year. Over that same second-quarter stretch in 2022, Skyrizi and Rinvoq pitched in total revenues of $1.84 billion. Overall, AbbVie’s immunology portfolio reached revenues of $7.21 billion in Q2, jumping up 19.2% on an operational basis.