Adalimumab Biosimilar Now Available at Significant Discount to Humira

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Boehringer Ingelheim has announced that its unbranded adalimumab (Humira) biosimilar—adalimumab-adbm—is now available at a low wholesale acquisition cost, according to a press release from the company.¹

What’s the Issue?

Boehringer Ingelheim’s unbranded adalimumab-adbm will be available at an 81% discount to adalimumab (Humira), making the medication more affordable and accessible to patients.

• Adalimumab-adbm is already available under the brand name Cyltezo, which is priced at a 5% discount to adalimumab (Humira).
• The biosimilar is a citrate-free formulation that is available in 3 doses as pre-filled syringes or 1 dose as a pre-filled autoinjector.

Why it Matters

Adalimumab-adbm was originally approved by the FDA in 2017 to treat multiple chronic inflammatory conditions. The medication then became the first and only FDA-approved interchangeable adalimumab (Humira) biosimilar in 2021.²

• An interchangeable biosimilar designation from the FDA means that the medication may be auto-substituted for the reference product by a pharmacist.
• To achieve interchangeable designation, a biosimilar must meet high FDA standards and may go through additional testing.
• A month’s supply of Humira costs nearly $7000, but adalimumab-adbm should only cost around $1000.

Expert Commentary

• “We understand that finding affordable medications is a persistent challenge for many, which is why we strive to ensure our products are widely accessible,” Stephen Pagnotta, executive director and biosimilar commercial lead at Boehringer Ingelheim, said in a release.¹ “Biosimilars are intended to contribute to the economic sustainability of healthcare systems, and it is our hope that this dual pricing approach will contribute to that sustainability, improve access to Adalimumab-adbm and help meet the varied needs of people with a variety of chronic inflammatory diseases.”
• “Biosimilars were established to provide more treatment options, increase patient access, and lower healthcare costs,” Dorothy McCabe, PhD, FCP, executive director of biosimilars at Boehringer Ingelheim, told Dermatology Times.³ “We’re confident in the value that [adalimumab-adbm] Cyltezo brings to the healthcare and patient communities, backed by a strong efficacy-safety profile established in clinical trials.”

In Depth Insights

Adalimumab-adbm’s efficacy is supported by VOLTAIRE-X, a phase 3, randomized, comparative clinical trial in which researchers evaluated multiple switches between the biosimilar and reference product.

• The study showed that adalimumab-adbm demonstrated pharmacokinetic equivalence, “highly similar” efficacy and immunogenicity, and comparable safety.
• The medication is approved to reduce signs and symptoms of multiple types of arthritis, as well as treat Crohn’s disease, ulcerative colitis, plaque psoriasis, and intermediate, posterior, and panuveitis.

Extra Reading

For more on this issue, check out these articles.

1. Cyltezo Biosimilar Now Available in United States. (Dermatology Times)
2. Express Scripts Adds Cyltezo to National Preferred Formulary. (Dermatology Times)

References

1. Adalimumab-adbm, Boehringer Ingelheim’s Interchangeable biosimilar to Humira®, now available at low wholesale acquisition cost. News Release. Boehringer Ingelheim. October 2, 2023. Accessed October 2, 2023. https://www.boehringer-ingelheim.com/us/press-releases/low-wac-interchangeable-biosimilar-now-available

2. Biscaldi L. Five Adalimumab Biosimilars Now Available in US Market. News Report. Drug Topics. July 5, 2023. Accessed October 2, 2023. https://www.drugtopics.com/view/five-adalimumab-biosimilars-now-available-in-us-market

3. Bader, K. Express Scripts Adds Cyltezo to National Preferred Formulary. News Report. Dermatology Times. July 13, 2023. Accessed October 2, 2023. https://www.drugtopics.com/view/express-scripts-adds-cyltezo-to-national-preferred-formulary