FDA Approves High Concentration, Citrate-Free Version of Cyltezo, Boehringer Ingelheim’s Humira Biosimilar for Chronic Inflammatory Diseases

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The FDA has approved Boehringer Ingelheim’s new high-concentration, citrate-free formulation of Cyltezo (adalimumab-adbm), a biosimilar to Humira, for the treatment of numerous chronic inflammatory diseases. The new version was approved partially based on promising data from the VOLTAIRE-HCLF Phase I clinical trial, which compared the bioavailability of high-concentration and low-concentration formulations of Cyltezo. According to the company, the new formulation is priced at a 5% discount to Humira under the brand name, with an 81% discount under the unbranded adalimumab-adbm.

By introducing the new formulation, Boehringer Ingelheim aims to enhance patient access to biologic treatments for diseases such as Crohn disease, ulcerative colitis, rheumatoid arthritis, and psoriasis.¹

"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, executive director, biosimilar commercial lead, Boehringer Ingelheim, in a press release. "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."

In 2021, the FDA approved Cyltezo as the first interchangeable biosimilar to Humira, following its initial approval for the treatment of multiple chronic inflammatory diseases in 2017. The interchangeable designation meant that the biosimilar could be substituted at the pharmacy level across all of Humira’s indications. For the interchangeability designation, the approval was supported by data collected from Boehringer Ingelheim's Phase III randomized VOLTAIRE-X clinical trial, which showed no significant differences between Cyltezo and Humira after evaluating for multiple switches.²

"As the first interchangeable biosimilar of Humira, Cyltezo (adalimumab-adbm), represents an important step toward bringing patients more affordable treatment options for complex, and often expensive, biologic reference products," said Martin Alan Menter, MD, chairman of the division of dermatology, Baylor University Medical Center, in a press release. "This is incredibly important for patients, who can be confident that once available, citrate-free Cyltezo has the same efficacy and safety as the originator medicine with the added benefit of cost savings."

The interchangeable biosimilar version of Cyltezo was first launched last July as a prefilled syringe or EpiPen.³

"The availability of a high-concentration and citrate-free Cyltezo is welcome news for people living with certain chronic inflammatory conditions, such as Crohn's disease and ulcerative colitis, which affect nearly one in 100 Americans," said Michael Osso, president, CEO, Crohn's & Colitis Foundation, in a press release. "The flexibility of having multiple biosimilar formulations to choose from is important to support broader patient access to biologic medicines."

According to a 2017 study from the Handbook of Systemic Autoimmune Diseases, inflammatory diseases are connected to increased cardiovascular (CV) morbidity and mortality. Additionally, CV risk is common in those suffering from inflammatory diseases.⁴

“Cardiovascular involvement in systemic inflammatory diseases is highly heterogeneous, with manifestations affecting the pericardium, cardiac muscle, endocardium and valves, conduction system, coronary arteries, pulmonary arterioles, great and small vessels of the systemic circulation, with an increased risk of major cardiovascular and cerebral complications,” wrote the authors of the study.

References

1. US FDA approves high-concentration, citrate-free formulation of Cyltezo® (adalimumab-adbm) injection, Boehringer Ingelheim's interchangeable* biosimilar to Humira®. 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. U.S. FDA Approves Cyltezo® (adalimumab-adbm) as First Interchangeable Biosimilar with Humira®. PR Newswire. October 15, 2021. Accessed May 1, 2024. https://www.prnewswire.com/news-releases/us-fda-approves-cyltezo-adalimumab-adbm-as-first-interchangeable-biosimilar-with-humira-301401610.html

3. Cyltezo®, first and only FDA-approved Interchangeable biosimilar to Humira®, now commercially available in the U.S. 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

4. Chapter 9 - New Cardiac Imaging Tools and Invasive Techniques in Systemic Autoimmune Diseases (Part II). Handbook of Systemic Autoimmune Diseases. Accessed May 1, 2024. https://doi.org/10.1016/B978-0-12-803997-7.00009-0