Cyltezo® (adalimumab-adbm), an interchangeable biosimilar to Humira® (adalimumab), will soon be available in a new autoinjector device, in addition to the prefilled syringe.
Cyltezo is a tumor necrosis factor (TNF) blocker approved for the following indications:
- Rheumatoid arthritis: To reduce signs and symptoms, induce major clinical response, inhibit the progression of structural damage, and improve physical function in adult patients with moderately to severely active rheumatoid arthritis; can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs).
- Juvenile idiopathic arthritis: To reduce signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older; can be used alone or in combination with methotrexate.
- Psoriatic arthritis: To reduce signs and symptoms, inhibit the progression of structural damage, and improve physical function in adult patients with active psoriatic arthritis; can be used alone or in combination with non-biologic DMARDs.
- Ankylosing spondylitis: To reduce signs and symptoms in adult patients with active ankylosing spondylitis.
- Crohn disease: Treatment of moderately to severely active Crohn disease in adults and pediatric patients 6 years of age and older.
- Ulcerative colitis: Treatment of moderately to severely active ulcerative colitis in adult patients.
- Plaque psoriasis: 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; should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician.
- Hidradenitis suppurativa: Treatment of moderate to severe hidradenitis suppurativa in adult patients.
The prefilled Cyltezo Pen 40mg/0.8mL will be available in 2-, 4- and 6-pack options on July 1, 2023. According to Boehringer Ingelheim, the pen was designed with patient-centered features to simplify the administration process.
“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,” said Stephen Pagnotta, Executive Director and Biosimilar Commercial Lead at Boehringer Ingelheim.
- US FDA approves the Cyltezo® Pen, a new autoinjector option, ahead of July 1 commercial launch. News release. May 22, 2023. https://www.prnewswire.com/news-releases/us-fda-approves-the-cyltezo-pen-a-new-autoinjector-option-ahead-of-july-1-commercial-launch-301830033.html.
- Cyltezo. Package insert. Boehringer Ingelheim; 2023. Accessed May 22, 2023. https://content.boehringer-ingelheim.com/DAM/9d0e3bae-9a17-4979-91bc-af1e011eeb8a/cyltezo-us-pi.pdf.