Skyrizi Overtakes Humira: “Product Hopping” Leaves Biosimilar Market in Limbo

Skyrizi (risankizumab-rzaa) has taken the sales crown away from Humira (reference adalimumab) for the first time, just under 2 years after the first biosimilar to Humira entered the US market, according to AbbVie’s financial report for the third quarter of 2024.¹

In AbbVie’s report, the company specified that worldwide net revenues for the quarter reached $14.460 billion, rising 3.8% on a reported basis and 4.9% on an operational basis. The immunology portfolio—containing Humira, Skyrizi, and Rinvoq (upadacitinib)—contributed $7.046 billion, growing 3.9% on a reported basis and 4.8% operationally.

Humira's global revenues fell to $2.227 billion, down 37.2% on a reported basis, with US sales declining 41.6% to $1.765 billion, while international sales decreased by 12.4% to $462 million. In contrast, Skyrizi saw a 50.8% global increase to $3.205 billion, and Rinvoq rose 45.3% to $1.614 billion.

Products like Humira, Skyrizi, and Rinvoq are used to treat plaque psoriasis, ankylosing spondylitis, juvenile idiopathic arthritis, rheumatoid arthritis, psoriatic arthritis, Crohn disease, and ulcerative colitis.

The news causes concerns as IQVIA data show that although the monthly fill volume for adalimumab biosimilars grew 400% from March 2024 to April 2024, there’s been a large drop in total adalimumab volume, which is attributed to the growth of Skyrizi and Rinvoq.²

A head-to-head phase 3 clinical trial evaluating Humira vs Skyrize in patients with moderate to severe plaque psoriasis found that more patients achieved 90% improved skin on Skyrizi compared with Humira (72% vs 47%).³ The study looked at 605 patients across 66 clinics in 11 countries. At 16 weeks, risankizumab showed superior efficacy, with 72% of patients achieving 90% skin clearance vs 47% with adalimumab.

In a follow-up phase, 66% of adalimumab responders who switched to risankizumab maintained high clearance versus 21% who continued adalimumab. Adverse events were similar across groups, supporting risankizumab as a more effective and safe long-term option for psoriasis treatment.

“Product hopping” refers to when drug companies shift demand from an innovator drug facing or about to face generic or biosimilar competition to new, patented versions.⁴ The practice can hinder competition by allowing companies to maintain near-monopolies by shifting patients taking blockbuster products to other products made by the same company in order to extend market exclusivity, oftentimes without significantly improving clinical outcomes for patients.

Initially, there was a lot of hope for adalimumab biosimilars to create a competitive adalimumab market and significantly bring down prices, especially as the US has 10 adalimumab biosimilars currently competing against the blockbuster originator.⁵ Although some of this hope has been realized, product hopping creates a complicated landscape for the sustainability of the adalimumab biosimilar space.

In January 2023, Amgen launched Amjevita (adalimumab-atto) on the US market, marking the first adalimumab biosimilar to become available to American patients.⁶ In July of the same year, 7 more Humira biosimilars launched (Cyltezo, Yusimry, Hadlima, Hyrimoz, Yuflyma, Idacio, and Hulio).^7-9 Simlandi, the tenth adalimumab biosimilar, was approved and launched in 2024.^10,11

By their 1-year anniversary, adalimumab biosimilars had captured only 2% market share, largely due to pharmacy benefit manager (PBM) and payer policies blocking access and favoring the reference agent.¹² However, as the year progressed, more PBMs and payers started adding the biosimilars to formulary lists, propelling the combined market share for these products to 22% by October 2024, according to a Samsung Bioepis report.¹³ This was largely in thanks to PBM giant Caremark shifting its formulary to include Hyrimoz and remove Humira.¹⁴

However, as was discussed during the recent GRx+Biosims conference, the progress of market adoption in the adalimumab space is offset by the massive adoption of Skyrizi and subsequent dwindling adoption of adalimumab overall.¹⁵

“What happened is AbbVie recognized, ‘Hey, [the introduction of Humira biosimilars] will be a potentially disastrous market event with one of the biggest blockbusters in history losing exclusivity. We've got to compete. We've got to launch these other brands with similar indications and get them going.’ So, 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,” explained panelist Nick Adolph, principal of US market access strategy at IQVIA Institute for Human Data Science.

During the discussion, panelists emphasized the need for greater transparency and policy reforms within PBM practices to improve biosimilar access and competition.¹⁶ The panelists advocated for simple reforms, such as fair access fees and formulary placement, to create a transparent, competitive market that supports biosimilar growth and cost savings.

On the policy front, in 2022, Congress instructed the Federal Trade Commission to report its actions on product hopping, leading to the agency publishing a report on the practice.¹⁷ The report emphasized that product hopping can raise antitrust concerns when the brand-name company attempts to obstruct fair competition between the original and reformulated drugs.

Additionally, in January 2023, Sens John Cornyn (R, Texas) and Richard Blumenthal (D, Connecticut) introduced the Affordable Prescriptions for Patients Act of 2023 (S 150), which passed a Senate vote in July 2024.¹⁸ If it became law, it would prohibit product hopping practices and limit the number of patents an innovator company is allowed to sue a generic or biosimilar manufacturer over to 20 patents, with specific rules about when new patents can be added. However, the bill has been “held at the desk” in the House since July 2024.

Despite this, Mary Jo Carden, head of policy at Sandoz, expressed hope for biosimilars to overcome product hopping issues during the GRx+Biosims discussion.¹⁶ “I do think we have challenges ahead, certainly, but [growing adalimumab adoption] does signal that there is a willingness for patients to access them, we just have to make sure that we have the right, common-sense solutions to ensure that that we have formulary access because it is really important to have a competitive marketplace for biologics, which is what biosimilars [provide]….We really need to strike a balance so that we have innovation and fair competition.”

References

1. AbbVie reports third-quarter 2024 financial results. AbbVie. News release; October 30, 2024. Accessed November 5, 2024. https://investors.abbvie.com/news-releases/news-release-details/abbvie-reports-third-quarter-2024-financial-results

2. Adalimumab biosimilar tracking: Q2-2024 refresh. IQVIA and Biosimilars Council. August 2024. Accessed November 5, 2024. https://biosimilarscouncil.org/wp-content/uploads/2024/08/202408-IQVIA-AAM-Adalimumab-Biosimilar-Launch-Tracking-Q3-Report.pdf 

3. Reich K, Gooderham M, Thaçi D, et al. Risankizumab compared with adalimumab in patients with moderate-to-severe plaque psoriasis (IMMvent): a randomised, double-blind, active-comparator-controlled phase 3 trial. Lancet. 2019;394(10198):576-586. doi:10.1016/S0140-6736(19)30952-3

4. Hagen T. Biopharmaceutical industry representatives discuss product hopping legislation. The Center for Biosimilars^®. September 24, 2020. Accessed November 5, 2024. https://www.centerforbiosimilars.com/view/biopharmaceutical-industry-representatives-discuss-product-hopping-legislation

5. Jeremias S. Part 1: biosimilars to bring a bumper crop of adalimumab options. The Center for Biosimilars. September 6, 2022. Accessed November 5, 2024. https://www.centerforbiosimilars.com/view/part-1-biosimilars-to-bring-a-bumper-crop-of-adalimumab-options

6. Jeremias S. US welcomes first adalimumab biosimilar, Amjevita. The Center for Biosimilars. January 31, 2024. Accessed November 5, 2024. https://www.centerforbiosimilars.com/view/us-welcomes-first-adalimumab-biosimilar-amjevita

7. Jeremias S. First round of adalimumab biosimilar launches in July. The Center for Biosimilars. July 2, 2024. Accessed November 5, 2024. https://www.centerforbiosimilars.com/view/first-round-of-adalimumab-biosimilar-launches-in-july

8. Jeremias S. Celltrion launches Yuflyma on the US market. The Center for Biosimilars. July 2, 2024. Accessed November 5, 2024. https://www.centerforbiosimilars.com/view/celltrion-launches-yuflyma-on-the-us-market

9. Jeremias S. US welcomes Idacio, Hulio to the adalimumab biosimilar market. The Center for Biosimilars. July 5, 2024. Accessed November 5, 2024. https://www.centerforbiosimilars.com/view/us-welcomes-idacio-hulio-to-the-adalimumab-biosimilar-market

10. Jeremias S. FDA approves 10th adalimumab biosimilar, Simlandi. The Center for Biosimilars. February 24, 2024. Accessed November 5, 2024. https://www.centerforbiosimilars.com/view/fda-approves-tenth-adalimumab-biosimilar-simlandi

11. Jeremias S. Eye on Pharma: Simlandi US launch; ranibizumab partnership; expanded access for adalimumab biosimilars. The Center for Biosimilars. May 27, 2024. Accessed November 5, 2024. https://www.centerforbiosimilars.com/view/eye-on-pharma-simlandi-us-launch-ranibizumab-partnership-expanded-access-for-adalimumab-biosimilars

12. Jeremias S. Happy birthday adalimumab biosimilars: reflecting on the first year of US competition. The Center for Biosimilars. January 31, 2024. Accessed November 5, 2024. https://www.centerforbiosimilars.com/view/happy-birthday-adalimumab-biosimilars-reflecting-on-the-first-year-of-us-competition

13. Jeremias S. Samsung Bioepis report showcases adalimumab biosimilar growth in market share. The Center for Biosimilars. October 11, 2024. Accessed November 5, 2024. https://www.centerforbiosimilars.com/view/samsung-bioepis-report-showcases-adalimumab-biosimilar-growth-in-market-share

14. CVS to remove Humira from some reimbursement lists in favor of biosimilar options. The Center for Biosimilars. January 6, 2024. Accessed November 5, 2024. https://www.centerforbiosimilars.com/view/cvs-to-remove-humira-from-some-reimbursement-lists-in-favor-of-biosimilar-options

15. Adolph N, Carden MJ, Sargent M. Humira biosimilar adoption: hints of progress or signs of doom? Presented at: GRx+Biosims; October 21-23, 2024; Rockville, MD.

16. Jeremias S. How policy reforms in PBM systems could change the adalimumab market. The Center for Biosimilars. October 28, 2024. Accessed November 5, 2024. https://www.centerforbiosimilars.com/view/how-policy-reforms-in-pbm-systems-could-change-the-adalimumab-market

17. Federal Trade Commission Report on Pharmaceutical Product Hopping. Federal Trade Commission. October 2022. Accessed November 5, 2024. https://www.ftc.gov/system/files/ftc_gov/pdf/p223900reportpharmaceuticalproducthoppingoct2022.pdf

18. Affordable Prescriptions for Patients Act of 2023, S 150, 118th Cong (2023). Accessed November 5, 2024. https://www.congress.gov/bill/118th-congress/senate-bill/150