AbbVie’s US Humira revenue fell 47% to $425 million in the second quarter of 2026, illustrating the pressure biosimilar competition can place on a leading medicine. For healthcare systems, that competition offers a route to lower spending, although savings depend on which products reach the market and how widely they are used.
The US figure was down from $802 million a year earlier, according to AbbVie’s quarterly filing. Globally, Humira revenue fell 36%, with the company attributing the decline primarily to continuing direct biosimilar competition following loss of exclusivity.
Humira treats inflammatory conditions. It belongs to a class of medicines called biologics, which are produced using living cells or organisms. Biosimilars are competing biological medicines assessed against an already approved product.
Competition without a conventional generic
The US Food and Drug Administration requires a biosimilar to be highly similar to its reference medicine, with no clinically meaningful differences in safety, purity or potency.
Biologics are more complex than conventional small-molecule medicines, whose active ingredients can generally be copied precisely for generic versions. Biosimilar approval relies on evidence comparing the products, including detailed analysis of their structure and function.
The financial stakes are substantial. The FDA reported that biologics accounted for about 5% of US prescriptions but 51% of drug spending in 2024 in its October 2025 announcement on biosimilar development.
For manufacturers of original medicines, competition increases the pressure to replace declining revenue. AbbVie’s newer immunology treatments Skyrizi and Rinvoq generated global second-quarter 2026 revenue of $5.505 billion and $2.525 billion respectively, both higher than a year earlier. Those are worldwide figures, separate from Humira’s US sales.
Medicare savings vary between medicines
A US Department of Health and Human Services analysis, published in January 2025, examined eight reference biologics facing competition from 27 biosimilars under Medicare Part B in 2023. Part B covers medical services and certain medicines, often administered in a clinical setting.
The analysis estimated that competition reduced programme spending and beneficiaries’ out-of-pocket costs on those medicines by about 62% compared with projected spending without biosimilar competition.
That was an estimate against a hypothetical no-competition scenario, not a 62% year-on-year fall across Medicare’s drug budget. Biosimilar uptake ranged from 26% to 80% depending on the medicine.
The variation limits how far the result can be applied to other products. Approval creates another treatment option; the financial return depends on its use and the prices paid.
FDA seeks to reduce development costs
In draft guidance announced on 9 March 2026, the FDA proposed reducing some pharmacokinetic testing, which measures how a medicine moves through the body, where scientifically justified.
The proposals describe circumstances in which developers could use data involving a comparator approved outside the US without additional three-way testing against the US reference product. The agency estimated potential savings of up to 50% of the relevant study costs, or approximately $20 million. These were projected development savings, not measured reductions in medicine prices.
The proposals followed an October 2025 draft addressing when comparative efficacy studies, which compare treatment effects, are necessary.
Lower development costs could make more products commercially viable for biosimilar manufacturers. Whether that produces broader price competition will still depend on companies entering those markets and healthcare providers and payers using the approved alternatives.
