As AbbVie inches toward the industry’s largest-ever patent cliff—Humira's in 2023—the company's execs sound more and more enthusiastic about the immunology drugs set to inherit the blockbuster's throne.
At a Bernstein conference this week, AbbVie’s vice chairman and president, Michael Severino, took an upbeat stance on Rinvoq and Skyrizi, the two drugs the company is counting on to help ease the pain from Humira biosimilars, according to a Thursday note from analyst Ronny Gal.
For Rinvoq, the company is anticipating an FDA decision in atopic dermatitis this summer. AbbVie expects its Rinvoq AD decision by July, and the company doesn’t expect an FDA advisory committee hearing to take place before then, Gal wrote. That's despite the safety questions now haunting the JAK inhibitor class.
In AD, the med would challenge Sanofi and Regeneron’s entrenched Dupixent. AbbVie’s commercial team is “ready to launch,” Gal wrote, paraphrasing Severino's comments, in both the 15 mg and 30 mg doses. Still, the rollout would be fine with just the lower dose, the exec said, according to the analyst.
AbbVie envisions the drug initially being used in the one-third of patients who aren’t getting enough benefit from Dupixent. In the long run, AbbVie sees its drug as competing in the first-line use. AbbVie expects the $4 billion AD market to triple in the next few years.
As for psoriasis med Skyrizi, AbbVie still sees a “long way to go” for both the drug and the overall market, Gal wrote. Initial biologic adoption has been slow, and AbbVie believes its med’s safety and efficacy profile can compete against meds including Johnson & Johnson's Tremfya.
Even after Humira loses exclusivity, AbbVie believes Skyrizi won’t suffer from cheaper Humira copycats and can stand “on its own,” Gal wrote.
AbbVie is counting on both drugs to carry the Humira torch after biosimilars hit the U.S. market in early 2023. Together, the newer drugs generated $2.3 billion last year; AbbVie says they can reach $15 billion by 2025.
Until then, all eyes are on the rollouts. But the Rinvoq launch hit a couple of snags in recent months.
In March and April, respectively, the FDA held up its applications for psoriatic arthritis and atopic dermatitis based on class-wide safety concerns for JAK inhibitors. As evidence of how closely AbbVie investors are watching Rinvoq’s progress, the first 3-month delay prompted a 6% stock decline for the company.
AbbVie’s Humira, the world’s bestselling medicine, will face staggered biosim entrants starting in January 2023. The drug is already battling biosimilars in Europe, and worldwide last year, it generated $19.8 billion, or 43% of the company's revenue.