FDA Approves Cyltezo Autoinjector Pen

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The US Food and Drug Administration (FDA) recently approved the Cyltezo (adalimumab-adbm) Pen, a new autoinjector option from Boehringer Ingelheim.¹ Adalimumab-adbm is an FDA-approved adalimumab (Humira) biosimilar that received interchangeability designation in October 2021. The 40 mg/0.8 mL pre-filled autoinjector pen will be available in 2, 4, and 6-pack options on July 1, 2023.

With patients in mind, the design of the pen features a one-button, 3-step activation, with 100% drug visibility and a protected needle. According to Boehringer Ingelheim, the Arthritis Foundation has certified the autoinjector pen as an “Ease of Use” product.

Stephen Pagnotta, the executive director and biosimilar commercial lead at Boehringer Ingelheim noted that “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. We’re excited to be able to offer the Cyltezo Pen as an additional option to patients at Cyltezo’s launch on July 1.”

With interchangeability status, adalimumab-adbm is one of the few adalimumab biosimilars able to effectively treat hidradenitis suppurativa, giving patients an additional treatment option for the burdensome disease.

Indications

Adalimumab-adbm was originally approved as a pre-filled to treat multiple chronic inflammatory diseases. Indications for adalimumab-adbm include¹:

Rheumatoid Arthritis: Indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. Adalimumab-adbm can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs).

Juvenile Idiopathic Arthritis: Indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older. Adalimumab-adbm can be used alone or in combination with methotrexate.

Psoriatic Arthritis: Indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. Adalimumab-adbm can be used alone or in combination with non-biologic DMARDs.

Ankylosing Spondylitis: Indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis.

Crohn’s Disease: Indicated for the treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older.

Ulcerative Colitis: Indicated for the treatment of moderately to severely active ulcerative colitis in adult patients. The effectiveness of adalimumab products has not been established in patients who have lost response to or were intolerant to TNF blockers.

Plaque Psoriasis: Indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. Adalimumab-adbm should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician.

Hidradenitis Suppurativa: Adalimumab-adbm is indicated for the treatment of moderate to severe hidradenitis suppurativa in adult patients.

Reference

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