Data Show Promise for Adalimumab Biosimilars to Deliver on Safety, Cost Savings

Two posters from the Academy of Managed Care Pharmacy’s annual meeting provided hope that despite low uptake so far, adalimumab biosimilars can deliver on the promise of comparable safety and efficacy with the originator in multiple disease states as well as cost savings.

Pooled Safety Analysis for Cyltezo in Multiple Disease States¹

One poster confirmed comparable safety, efficacy, and immunogenicity of adalimumab-adbm (Cyltezo; Boehringer Ingelheim) with the originator (Humira; AbbVie).

The researchers evaluated the results of the VOLTAIRE studies, which looked at Cyltezo use in moderate to severe rheumatoid arthritis (RA), Crohn disease (CD), and chronic psoriasis (PsO). The pooled analysis included data from 5 VOLTAIRE trials involving patients who had received at least 1 dose of Cyltezo or Humira.

Cyltezo is available in high- and low-concentration formulations. It was originally approved in August 2017, with the high-concentration approval occurring May 2024, 10 months after the original formulation launched on the US market.

By study, VOLTAIRE-RA included 645 patients and lasted 58 weeks, VOLTAIRE-RAext included 225 patients and lasted 58 weeks, VOLTAIRE-CD had 147 patients and was 56 weeks long, VOLTAIRE-PSO had 317 patients and went 34 weeks, and VOLTAIRE-X involved 259 patients with plaque psoriasis and went 58 weeks. There were more female patients with RA and more male patients with CD and PsO. A vast majority of patients identified as White and the ages ranged from 18 to 80 years.

Safety end points were adverse events (AEs), serious AEs (SAEs), discontinuations resulting from AEs, deaths, and AEs resulting in serious infections as well as malignancies, and major adverse cardiovascular events (MACE; defined as nonfatal stroke, myocardial infarction, or cardiovascular death). Exposure-adjusted incidence rates were calculated per 100 patient-years.

Results demonstrated no statistically significant differences between the 2 products in RA, CS, and PsO regarding the rate of AEs, SAEs and discontinuations due to AEs. Additionally, there were no differences between therapies in the rate of deaths, AEs resulting in serious infections, cancer, or MACE. Any menial differences between trials appeared to be driven by complications common to the respective patient populations and disease landscapes rather than the treatments themselves.

Cost Savings Associated With Hadlima²

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A second poster showed that 2% uptake of adalimumab-bwwd (Hadlima; Organon and Samsung Bioepis) could generate $25,277,471 in reduced 1-year drug acquisition costs.

Researchers tested the biosimilar in a hypothetical plan population of 1 million members enrolled in a US third-party commercial plan over a 1-year time horizon. The study was designed to predict the budgetary impact and cost savings associated with formulary changes from reference adalimumab to adalimumab-bwwd across several diseases.

Hadlima is one of the few adalimumab biosimilars to be available with low- and high-concentration formulations. The low-concentration version was approved in July 2019 and the high-concentration version was approved in August 2022. Both versions launched in the US in July 2023. Hadlima has a wholesale acquisition cost that is significantly lower than that of Humira, launching at $519 per dose (vs $3461 for Humira in Q3 2023).

Microsoft Excel was used to develop a budget impact model that is able to:

• Have a flexible time horizon up to 5 years
• Capture drug acquisition costs and market share
• Account for multiple adalimumab biosimilars
• Conduct an automated one-way sensitivity analysis
• Incorporate all approved indications for Hadlima separately or in combination with other therapies

The researchers assessed the biosimilar and reference agent in plaque psoriasis, rheumatoid arthritis, ankylosing spondylitis, adult and pediatric Crohn disease, psoriatic arthritis, ulcerative colitis, juvenile idiopathic arthritis, hidradenitis suppurativa, and uveitis.

Results showed that the savings generated from switching 2% of patients from the originator to the biosimilar is equivalent to an incremental savings of $2.11 per member per month.

The study had some limitations, including that the use of publicly available price and epidemiological data may not be fully representative of a real-world population. Additionally, the model did not capture benefits to patients through reduced co-pay programs.

References

1. Cohen S, Bender S, Shaberman A, Vinisko R, McCabe D. Pooled safety analysis from the VOLTAIRE trials in patients with rheumatoid arthritis, Crohn’s disease, and chronic plaque psoriasis. Presented at: AMCP 2024; April 15-18, 2024; New Orleans, LA. Poster M6.

2. Goodall G, Badaracco J, Dupclay L. Adalimumab-bwwd, a biosimilar of adalimumab, has the potential for substantial cost savings when prescribed. Presented at: AMCP 2024; April 15-18, 2024; New Orleans, LA. Poster M1.