FDA Approves High-Concentration, Citrate-Free Cyltezo for the Treatment of Chronic Inflammatory Diseases


This citrate-free and high-dose approval of the biosimilar Humira provides another option to treat patients who are living with various inflammatory diseases.

The FDA has approved a high-concentrated, citrate-free formulation of adalimumab-adbm (Cyltezo; Boehringer Ingelheim), a biosimilar to Humira (adalimumab; AbbVie), for the treatment of multiple chronic inflammatory diseases. The approval is partly based on data from the phase 1 clinical trial, VOLTAIRE-HCLF (NCT05203289).1

Adalimumab injections -- Image credit: luchschenF | stock.adobe.com

Image credit: luchschenF | stock.adobe.com

Adalimumab-adbm is a tumor necrosis factor (TNF) blocker that can be used to reduce the signs and symptoms of moderate to severe rheumatoid arthritis in adults; moderate to severe polyarticular juvenile idiopathic arthritis in children 2 years of age and older; psoriatic arthritis, ankylosing spondylitis, and moderate to severe hidradenitis suppurativa in adults; moderate to severe ulcerative colitis in adults; and Crohn disease in both adults and children aged 6 years and older.1,2

In May 2023, an autoinjector form of adalimumab-adbm was approved for these diseases, and it is currently available as a pre-filled syringe or autoinjector. The autoinjector pen features a single-button, 3-step activation, 100% drug visibility, and a protected needle that is intended to be easily used by patients who have arthritis. A high-concentration (100 mg/mL) and a citrate-free, low-concentration (50 mg/mL) dose are currently available.1,2

"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 1 in 100 Americans," said Michael Osso, president and CEO of the 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."1

About the Trial

Trial Name: 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

ClinicalTrials.gov ID: NCT05203289

Sponsor: Boehringer Ingelheim

Completion Date: August 29, 2022

VOLTAIRE-HCLF is a double-blind, single-dose, randomized, parallel-arm phase 1 that evaluated and compared the pharmacokinetics of 40 mg/0.4 mL and 40 mg/0.8 mL pre-filled syringe injections of Cyltezo in healthy adults aged 18 to 55 years over a 14-week duration. A total of 200 patients were enrolled, with receiving 99 the 40 mg/0.4 mL dose and 101 receiving the 40 mg/0.8 mL dose.3

"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, in the press release. "We stand united with our patients and health care providers in the effort to accelerate the adoption of biosimilars, which benefit patients as well as the larger health care ecosystem."1

Adverse events (AEs) reported by patients who received treatment with adalimumab-adbm include serious infections, allergic reactions, nervous system complications (eg, dizziness, numbness, weakness in arms and legs), heart failure, immune reactions, rash, headache, injection site reactions, and new or worsening of psoriasis. In the VOLTAIRE-HCLF trial, AEs reported were nonserious, and included injection site reactions and headache. Additionally, no patients died during treatment.1-3

"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 and biosimilar commercial lead at Boehringer Ingelheim, in the 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."1

1. PR Newswire. US FDA approves high-concentration, citrate-free formulation of Cyltezo® (adalimumab-adbm) injection, Boehringer Ingelheim's interchangeable* biosimilar to Humira®. News release. 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. Gallagher, A. FDA Approves Biosimilar Adalimumab-adbm in Autoinjector Form. Pharmacy Times. May 23, 2023. Accessed May 1, 2024. https://www.pharmacytimes.com/view/fda-approves-biosimilar-adalimumab-adbm-in-autoinjector-form
3. 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. ClinicalTrials.gov identifier: NCT05203289. Updated March 15, 2024. Accessed May 1, 2024. https://clinicaltrials.gov/study/NCT05203289
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