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Optum Rx, a pharmacy benefit manager and subsidiary of UnitedHealth Group covering more than 66 million commercial insured members, will place the biosimilar adalimumab-adbm (Cyltezo) injection on its commercial formulary as a preferred brand, according to a statement from Boehringer Ingelheim.1
The drug, a US Food and Drug Administration (FDA)-approved interchangeable biosimilar to adalimumab (Humira), was initially approved in 2017. It is approved for the treatment of chronic inflammatory conditions, including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, Crohn’s disease, ulcerative colitis, plaque psoriasis, and ankylosing spondylitis.
“Optum Rx’s decision to add Cyltezo to its formulary could benefit millions of Americans, improving access to a crucial medicine that has been a safe and effective treatment for many inflammatory conditions for the last two decades,” Stephen Pagnotta, Executive Director and Biosimilar Commercial Lead at Boehringer Ingelheim, stated. “We are proud to bring our many decades of experience in complex biologics to the biosimilar space, enabling physicians and patients to feel confident in the science, interchangeability, and manufacturing of Cyltezo.”
Adalimumab-adbm is subcutaneously administered via a 40 mg/0.8 mL pre-filled Cyltezo Pen. The drug, which was previously granted an FDA approval for the supplemental Biologics License Application (sBLA) in October 2021, will be commercially available in the United States on July 1, 2023.
In May 2023, the FDA approved of the adalimumab-adbm autoinjector pen ahead of it’s July launch date. It will be available in 2-, 4-, and 6-pack options. It received an “Ease of Use” demarcation by The Arthritis Foundation, which recognizes devices that make everyday tasks easier for patients living with arthritis.2 The pen features a 1-button, 3-step activation with a protected needle and 100% drug visibility.
Patients receiving adalimumab products, including the adalimumab-adbm biosimilar, are at an increased risk for developing serious infections, particularly if they are taking concomitant methotrexate or corticosteroids. Therefore, those with chronic or recurrent infection, underlying conditions that predispose them to infection, or those with a history of opportunistic infection should consider the risks and benefits of treatment prior to initiating therapy. The most common adverse reactions were upper respiratory infection and sinusitis, headache, rash, and injection site reactions.
Biosimilars are defined as biologic medicines developed to be highly similar to an approved reference biologic and show no clinically meaningful differences in terms of safety, efficacy, and purity.
Interchangeable biosimilars, like adalimumab-adbm, can be auto-substituted for the reference product at a pharmacist’s discretion. To be designated as an interchangeable biosimilar, the drug must meet the high FDA standards of a biosimilar in addition to undergoing supplementary studies, often including a switching study which includes the switching of multiple substitutions in patients. Results of the study must show that switching does not increase the risk of safety or reduce efficacy when compared with remaining on the reference drug.