FDA Approves Biosimilar Adalimumab-adbm in Autoinjector Form

The FDA has approved the Cyltezo Pen (adalimumab-adbm; Boehringer Ingelheim), which is an autoinjector option of Cyltezo.Adalimumab-adbm is approved by the FDA as an interchangeable biosimilar to Humira.¹

"The FDA approval of the Cyltezo Pen is great news for patients living with chronic inflammatory diseases who may prefer administering the medication needed to manage their conditions via an autoinjector," Stephen Pagnotta, executive director and biosimilar commercial lead at Boehringer Ingelheim, said in a press release.¹ "We're excited to be able to offer the Cyltezo Pen as an additional option to patients at Cyltezo's launch on July 1."

Hands of an older adult with arthritis | Image credit: doucefleur - stock.adobe.com

Cyltezo was initially approved as a pre-filled syringe, indicated to treat multiple chronic inflammatory diseases. The pre-filled pens are available in 40 mg/0.8 mL dosages and will be available in 2-, 4-, and 6-packs on July 1, 2023.¹

Indications include rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn disease, ulcerative colitis, plaque psoriasis, and hidradenitis suppurativa.¹

The most common adverse effects listed for Cyltezo include infections, injection site reactions, headache, and rash.¹

The design of the pen features a one-button, 3-step activation, 100% drug visibility, and a protected needle, intended for patients’ ease of use.¹ Additionally, the Arthritis Foundation has certified the pen as an “Ease of Use” product.¹ According to the Arthritis Foundation, the Ease of Use program identifies products that are arthritis friendly and make tasks easier for those who live with arthritis.²

The Arthritis Foundation states that arthritis is the leading cause of disability in the United States, with approximately 54 million adults living with arthritis and approximately 300,000 children.² By 2024, the CDC projects than an estimated 78 million individuals aged 18 years and older will have physician-diagnosed arthritis.³

From 2013 to 2015, the CDC reported that 7.1% of individuals aged 18 to 44, 29.3% of individuals aged 45 to 64, and 49.6% of those 65 years and older had arthritis.³ The risk of arthritis is more common among women than men, with 26% of women and 19.1% of men having arthritis from 2013 to 2015.³

Additionally, the CDC reported that approximately 4.4 Hispanic adults, 41.3 million Non-Hispanic White adults, 6.1 million Non-Hispanic Black adults, and 1.5 million Non-Hispanic Asian adults had reported physician-diagnosed arthritis.³

The new approval comes in May, which is Arthritis Awareness Month, according to the CDC.³

Reference

1. US FDA approves the Cyltezo Pen, a new autoinjector option, ahead of July 1 commercial launch. News release. Boehringer Ingelheim. May 22, 2023. Accessed May 23, 2022. https://www.boehringer-ingelheim.com/us/press-releases/fda-approves-autoinjector-pen-interchangeable-biosimilar

2. Arthritis Foundation. Ease of use certification program. Arthritis Foundation. Accessed May 23, 2o23. https://www.arthritis.org/partnership/ease-of-use-certification

3. Centers for Disease Control and Prevention. Arthritis related statistics. CDC. Updated October 12, 2021. Accessed May 23, 2023. https://www.cdc.gov/arthritis/data_statistics/arthritis-related-stats.htm