FDA Approves Biosimilar Adalimumab-adbm Autoinjector Pen

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The US Food and Drug Administration (FDA) has approved the adalimumab-adbm (Cyltezo) autoinjector pen ahead of the July 1 commercial launch, according to a statement from Boehringer Ingelheim. The drug is an FDA-approved interchangeable biosimilar to adalimumab (Humira) and is used to treat a variety of chronic inflammatory diseases, including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, plaque psoriasis, Crohn’s disease, and ulcerative colitis. The pre-filled pen will be available in 2-, 4-, and 6-pack options.

Touted by The Arthritis Foundation as an “Ease of Use” product, which recognizes devices that make everyday tasks easier for patients living with arthritis, the pen features a 1-button, 3-step activation with a protected needle and 100% drug visibility.

"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. "We're excited to be able to offer the Cyltezo Pen as an additional option to patients at Cyltezo's launch on July 1."1

About Adalimumab-adbm

Adalimumab-adbm is subcutaneously administered via a 40 mg/0.8 mL pre-filled Cyltezo Pen. The most common adverse reactions, occurring in >10% of patients, included upper respiratory infections, sinusitis, injection site reactions, rash, and headache. An increased risk of serious infections has been reported in receiving adalimumab products, particularly in patients treated with concomitant immunosuppressants including corticosteroids and methotrexate.

About Biosimilars

Biosimilars are designed to have no clinically meaningful differences regarding safety, efficacy, and purity. Interchangeable biosimilars, such as adalimumab-adbm, produce the same result as the reference drug and patients can switch between the 2 without increased risks or reduced efficacy.2 They can also be auto-substituted for the reference product by a pharmacist.
“Through novel biologics and our interchangeable biosimilar, we strive to increase the availability of safe, effective, high-quality therapeutic options to patients worldwide,” the press release stated.


  1. Boehringer Ingelheim Pharmaceuticals, Inc. (2023, May 22). US FDA approves the Cyltezo® Pen, a new autoinjector option, ahead of July 1 commercial launch. PR Newswire: press release distribution, targeting, monitoring and marketing.
  2. Pine, L. (2021, October 18). FDA approves Adalimumab-adbm (cyltezo), interchangeable biosimilar to Adalimumab. HCP Live.