FDA approves autoinjector option for upcoming adalimumab biosimilar
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Key takeaways:
- The FDA has approved a new autoinjector pen option for Cyltezo, an interchangeable biosimilar to Humira.
- Cyltezo is scheduled to debut on the U.S. marketplace on July 1.
The FDA has given the green light to a new autoinjector option for the interchangeable adalimumab biosimilar Cyltezo, just weeks ahead of its scheduled debut in the United States, according to a press release from the manufacturer.
“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 the release. “We’re excited to be able to offer the Cyltezo pen as an additional option to patients at Cyltezo’s launch on July 1.”
Come July 1, Cyltezo (adalimumab-adbm, Boehringer Ingelheim) will be available in a pen that features a “one-button, three-step activation,” with a protected needle, according to the release. The 40 mg/0.8 mL pre-filled Cyltezo pen will be available in two-, four- and six-pack options. Previously, the drug was to be solely administered through a pre-filled syringe.
In 2021, Cyltezo became the first approved interchangeable biosimilar to treat certain inflammatory diseases, allowing pharmacists to substitute it for Humira (adalimumab, AbbVie) without the need for the prescriber to alter the prescription. It was just the second interchangeable biosimilar product ever approved by the FDA, and the first monoclonal antibody.
The FDA first approved Cyltezo as a biosimilar for Humira (adalimumab, AbbVie), the highest-grossing drug in the world, in 2017. However, its commercial debut was stymied as part of a volley of legal actions brought on by AbbVie against any company seeking to release a biosimilar for its prized Humira, a product that netted the company $16 billion in U.S. revenue, and $19.8 billion in global revenue, in 2020 alone.
AbbVie and Boehringer Ingelheim ultimately reached a settlement in 2019, clearing the way for Cyltezo to be released in the United States starting July 1, with royalties paid to AbbVie. It is one of several FDA-approved Humira biosimilars to make their U.S. commercial debut this year, as per the terms of the various settlement agreements between the drug makers.
The drug is approved for adults with moderate to severe rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis, as well as moderate to severe Crohn’s disease, ulcerative colitis and chronic plaque psoriasis. Cyltezo is also indicated for moderate to severe polyarticular juvenile idiopathic arthritis in patients aged 2 years and older, and in children aged 6 years and older with Crohn’s disease.
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