Humira's U.S. patent exclusivity ended in 2023, and AbbVie is now living with the consequences. The blockbuster drug, which once generated more than $20 billion a year, is facing biosimilar competition, and the company's latest earnings show Humira sales dropping as expected. But AbbVie has a plan: let Humira fade while pushing two newer drugs — Skyrizi and Rinvoq — to take its place.
The Post-Humira Landscape
Humira lost patent protection in Europe years ago, and the U.S. followed in 2023. That opened the door for biosimilars, including interchangeable versions like Cyltezo, which the FDA validated. AbbVie's response has been to accept the decline rather than fight it. The company is instead focusing resources on Skyrizi and Rinvoq, both of which have been approved for multiple indications and are showing strong year-over-year growth and sequential gains in recent earnings reports.
Biosimilar competition is now a reality. Payers have more options, and AbbVie's Humira revenue is shrinking. The question is whether the two newer drugs can fill the gap.
Skyrizi and Rinvoq: The New Pillars
Skyrizi (risankizumab) is an IL-23 inhibitor. It's approved for moderate to severe plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. Rinvoq (upadacitinib) is a selective JAK inhibitor, cleared for rheumatoid arthritis, atopic dermatitis, psoriatic arthritis, ankylosing spondylitis, axial spondyloarthritis, ulcerative colitis, and Crohn's disease. Both drugs have been expanding into new indications, giving AbbVie a broad portfolio to pitch to doctors and insurers.
Management has suggested that Skyrizi and Rinvoq are positioned to ultimately surpass Humira's contribution over time. That's a bold claim, given Humira's peak sales. But the early numbers are promising: the two drugs together are growing fast, and AbbVie is betting that their combined reach across inflammatory diseases will create a new revenue base.
Market Access Hurdles
Getting there won't be easy. Market access challenges include payer pressure, prior authorization requirements, step therapy, and rebates. For Rinvoq, there's additional scrutiny on the JAK inhibitor class, following safety concerns that have led to label warnings. AbbVie will have to navigate these obstacles while also competing with other biologics and biosimilars in the same therapeutic areas.
Step therapy, where insurers require patients to try cheaper drugs first, could slow adoption. Prior authorization adds administrative burden. And rebates — the discounts drugmakers give to pharmacy benefit managers — will eat into net revenue. AbbVie's margins and cash flow durability will depend on how well it manages these pressures.
Management's Outlook
In recent earnings calls, AbbVie executives have emphasized the strength of Skyrizi and Rinvoq. They point to the drugs' multiple indications and the company's ability to compete on efficacy and safety profiles. The goal is to maintain AbbVie's moat — the competitive advantage that Humira once provided — through a new generation of products.
But the impact of generics and biosimilars on that moat is real. Humira's decline is a reminder that even the biggest blockbusters eventually face competition. AbbVie's strategy is clear: replace one megablockbuster with two fast-growing successors. The unresolved question is whether Skyrizi and Rinvoq can overcome the market access hurdles and truly match Humira's peak — or whether the post-patent era will bring a new normal for AbbVie's bottom line.
