AbbVie's Skyrizi (risankizumab-rzaa) has overtaken Humira (adalimumab) in U.S. sales for the first time, signaling a significant shift in the pharmaceutical landscape amid increasing biosimilar competition. This change comes just under two years after the initial launch of Humira biosimilars in the U.S.
According to AbbVie's third-quarter 2024 financial report, worldwide net revenues reached $14.460 billion, a 3.8% increase on a reported basis. The immunology portfolio, encompassing Humira, Skyrizi, and Rinvoq (upadacitinib), contributed $7.046 billion, reflecting a 3.9% growth.
Sales Performance
Humira's global revenues experienced a substantial decline, falling to $2.227 billion, a 37.2% decrease. U.S. sales specifically dropped by 41.6% to $1.765 billion. In stark contrast, Skyrizi witnessed a 50.8% global increase, reaching $3.205 billion, while Rinvoq rose by 45.3% to $1.614 billion.
Impact of Product Hopping
The rise of Skyrizi and Rinvoq is attributed to a practice known as "product hopping," where pharmaceutical companies strategically shift demand from drugs facing biosimilar competition to newer, patented versions. This tactic can maintain market exclusivity without necessarily improving clinical outcomes for patients.
Nick Adolph, principal of U.S. market access strategy at IQVIA Institute for Human Data Science, noted that AbbVie anticipated the impact of Humira biosimilars. "Both these brands have really successful launches, and a lot of that has been due to moving patients over to these other products. And so, the total size of the adalimumab pie has really shrunk. So, even if biosimilars get the uptake, they're getting share in a market that is getting smaller and smaller."
Clinical Evidence
A head-to-head phase 3 clinical trial, IMMvent, comparing Humira and Skyrizi in patients with moderate-to-severe plaque psoriasis demonstrated that Skyrizi achieved superior skin clearance. At 16 weeks, 72% of patients on risankizumab achieved a 90% improvement in skin condition compared to 47% on adalimumab. The study involved 605 patients across 66 clinics in 11 countries.
Biosimilar Market Dynamics
Despite the introduction of ten adalimumab biosimilars in the U.S., these products initially captured only a small market share due to pharmacy benefit manager (PBM) and payer policies. However, increased formulary inclusion has propelled their combined market share to 22% by October 2024.
Policy and Legislative Efforts
To address product hopping, the Federal Trade Commission published a report in 2022 highlighting antitrust concerns. Additionally, the Affordable Prescriptions for Patients Act of 2023 (S. 150) aims to prohibit product hopping practices and limit the number of patents an innovator company can assert against generic or biosimilar manufacturers.
Call for Transparency
Panelists at the GRx+Biosims conference emphasized the need for greater transparency and policy reforms within PBM practices to enhance biosimilar access and competition. Mary Jo Carden, head of policy at Sandoz, expressed optimism about overcoming product hopping issues through common-sense solutions that ensure formulary access and a competitive marketplace.
