FDA Approves Second Formulation of Humira Biosimilar Cyltezo


According to Michael Osso, president and chief executive officer of the Crohn’s & Colitis Foundation, “the flexibility of having multiple biosimilar formulations to choose from is important to support broader patient access to biologic medicine.”

The FDA has approved adalimumab-adbm (Cyltezo), Boehringer Ingelheim’s high-concentration, citrate-free, interchangeable Humira (adalimumab; AbbVie) biosimilar, to treat several chronic inflammatory diseases, the company announced in a release.1

Boehringer Ingelheim logo on building / nmann77 - stock.adobe.com

Boehringer Ingelheim logo on building / nmann77 - stock.adobe.com

Adalimumab-adbm is indicated 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 and older; psoriatic arthritis in adults; ankylosing spondylitis in adults; and moderate-to-severe hidradenitis suppurativa in adults. It is further indicated to treat moderate-to-severe Crohn’s disease in adults and children 6 years of age and older; moderate-to-severe ulcerative colitis in adults; moderate-to-severe chronic plaque psoriasis in adults; and non-infectious intermediate, posterior, and panuveitis in adults.


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 Identifier: NCT05203289

Sponsor: Boehringer Ingelheim

Summary: The main objective of this trial is to compare the pharmacokinetics (PK) of 40 mg BI 695501 100 mg/mL with 40 mg BI 695501 50 mg/mL following single subcutaneous administration.

The FDA approval was partially supported by positive data from VOLTAIRE-HCLF (NCT05203289), a phase 1 clinical trial that compared the bioavailability of high-concentration and low-concentration formulations of adalimumab-adbm.

Adalimumab-adbm joins Boehringer Ingelheim’s portfolio of biosimilars as the second formulation of Cyltezo, the first being a low-concentration (50 mg/mL), citrate-free formulation made commercially available in July 2023. The high-concentration formula (100 mg/mL) is now available as a pre-filled syringe or pre-filled autoinjector; it is priced 5% lower than Humira under the brand name Cyltezo and 81% lower than Humira as the unbranded product adalimumab-adbm.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 and biosimilar commercial lead at Boehringer Ingelheim in a statement.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-abdm offerings.”

READ MORE: FDA: Simlandi Becomes Third Interchangeable Humira Biosimilar After Approval

According to Michael Osso, president and chief executive officer of the Crohn’s & Colitis Foundation, in a release, “the flexibility of having multiple biosimilar formulations to choose from is important to support broader patient access to biologic medicine.”1

“Biologics and biosimilars are a crucial treatment option for many living with psoriatic arthritis or psoriasis,” said Leah M. Howard, JD, president and chief executive officer of the National Psoriasis Foundation, echoing Osso’s sentiments about expanding patient access to adalimumab.1 “We welcome the introduction of this additional formulation to expand the array of options available to our community.”

Cyltezo was originally approved as the first interchangeable biosimilar—meaning it's able to be substituted for the reference product without requiring a prescription change—to Humira on October 15, 2021, supported by efficacy and safety data from the phase 3 randomized VOLTAIRE-X comparative clinical trial. The study demonstrated that switching multiple times from Humira to Cyltezo produced similar clinical outcomes in terms of pharmacokinetics, efficacy, immunogenicity, and safety among 238 patients with moderate-to-severe chronic plaque psoriasis.2

“This first-of-its-kind switching study further reinforces our goal to broaden access to biosimilar treatment options while contributing to the quality and sustainability of health care systems,” said Thomas Seck, senior vice president of medicine and regulatory affairs at Boehringer Ingelheim in a release announcing the results from the trial.2

The approval of adalimumab-adbm, along with the previously established interchangeability of Cyltezo, represents a significant step towards improving affordability and accessibility of adalimumab treatment for patients in the US.

READ MORE: Biosimilar Resource Center

1. US FDA approves high-concentration, citrate-free formulation of Cyltezo (adalimumab-adbm) injection, Boehringer Ingelheim’s interchangeable biosimilar to Humira. News release. Boehringer Ingelheim. May 1, 2024. Accessed May 1, 2024. https://www.boehringer-ingelheim.com/us/fda-approves-additional-formulation-biosimilar
2. VOLTAIRE-X phase III data in patients with moderate-to-severe chronic plaque psoriasis support interchangeability application. News release. PR Newswire. April 23, 2021. Accessed May 1, 2024. https://www.prnewswire.com/news-releases/voltaire-x-phase-iii-data-in-patients-with-moderate-to-severe-chronic-plaque-psoriasis-support-interchangeability-application-301275511.html
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