FDA Approves A High-Concentration, Citrate-Free Version of Cyltezo, A Biosimilar to Humira

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The US Food and Drug Administration (FDA) has approved a high-concentration, citrate-free formulation of Boehringer Ingelheim's adalimumab-adbm (Cyltezo), a biosimilar to adalimumab (Humira), for chronic inflammatory conditions including psoriasis, psoriatic arthritis, hidradenitis suppurativa, and more.¹

Currently, Cyltezo, available in both high-concentration (100 mg/mL) and low-concentration (50 mg/mL) formulations, is offered at competitive prices compared to Humira. The high-concentration version is sold at a 5% discount under the brand name Cyltezo and at an 81% discount when unbranded as adalimumab-adbm.

The low-concentration, citrate-free version has been available to patients since July of last year, when Cyltezo became the first and only FDA-approved Interchangeable biosimilar to Humira.²

"With this FDA approval, we are now able to offer both high- and low-concentration, citrate-free formulations of Cyltezo, further expanding treatment access for patients living with certain chronic inflammatory diseases," said Stephen Pagnotta, the executive director and biosimilar commercial lead of Boehringer Ingelheim, in a news release.¹ "Many patients are treated with high-concentration adalimumab formulations, and we are excited to add this new option to our approved citrate-free Cyltezo and Adalimumab-adbm offerings."

The approval is partially based on positive data stemming from the phase 1 clinical trial VOLTAIRE-HCLF (NCT05203289). The double blind, randomized, single dose, parallel arm study compared the pharmacokinetics and bioavailability of low versus high concentrations of adalimumab-adbm (40 mg/0.4 mL versus 40 mg/0.8 mL).³

The US-based study included healthy men and women between the ages of 18 and 55 with a body mass index ranging from 18.5 to 29.9 kg/m². They were required to undergo a thorough medical evaluation, including physical examination, vital sign assessment, electrocardiogram, and laboratory tests, as determined by investigators.

Participants of reproductive age were asked to commit to using highly effective birth control methods with a failure rate of less than 1% annually, starting at least 30 days before the trial began and continuing until 30 days after its completion.

Leaders of various patient-facing organizations expressed gratitude and excitement at the approval, including leaders from the Arthritis Foundation and the National Psoriasis Foundation.

"This FDA approval is another step forward for people with chronic and often debilitating diseases such as rheumatoid and psoriatic arthritis," said Steven Taylor, president & CEO of the Arthritis Foundation.¹ "We stand united with our patients and healthcare providers in the effort to accelerate the adoption of biosimilars, which benefit patients as well as the larger healthcare ecosystem."

Leah Howard, JD, president and CEO of the National Psoriasis Foundation, echoed the sentiment.

"Biologics and biosimilars are a crucial treatment option for many living with psoriatic arthritis or psoriasis," Howard said.¹ "We welcome the introduction of this additional formulation to expand the array of options available to our community."

References

1. US FDA approves high-concentration, citrate-free formulation of Cyltezo (adalimumab-adbm) injection, Boehringer Ingelheim's interchangeable biosimilar to Humira. News release. PR Newswire. May 1, 2024. Accessed May 1, 2024. https://www.prnewswire.com/news-releases/us-fda-approves-high-concentration-citrate-free-formulation-of-cyltezo-adalimumab-adbm-injection-boehringer-ingelheims-interchangeable-biosimilar-to-humira-302132457.html
2. Cyltezo, first and only FDA-approved Interchangeable biosimilar to Humira, now commercially available in the U.S. News release. Boehringer Ingelheim. July 1, 2023. Accessed May 1, 2024. https://www.boehringer-ingelheim.com/us/human-health/skin-and-inflammatory-diseases/biosimilars/cyltezor-first-and-only-fda-approved
3. ClinicalTrials.gov. A study in healthy people to test how 2 different formulations of BI 695501 are taken up by the body when given as an injection. National Library of Medicine. Last updated March 15, 2024. Accessed May 1, 2024. https://clinicaltrials.gov/study/NCT05203289