FDA approves Cyltezo as first interchangeable biosimilar for inflammatory disease
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The FDA has designated Cyltezo the first approved interchangeable biosimilar to treat certain inflammatory diseases, allowing pharmacists to substitute it for Humira without the need for the prescriber to alter the prescription.
According to the FDA, Cyltezo (adalimumab-adbm, Boehringer Ingelheim) is just the second interchangeable biosimilar product approved by the agency, and the first monoclonal antibody. The FDA approved the first interchangeable biosimilar insulin product in July.
“The biosimilar and interchangeable approval pathway was created to help increase access to treatment options for patients with serious medical conditions,” Janet Woodcock, MD, acting FDA commissioner, said in an agency press release. “We continue to be steadfast in our commitment to provide patients with alternative high-quality, affordable medications that are proven to be safe and effective.”
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, 2023, with royalties paid to AbbVie. It will be one of six FDA-approved Humira biosimilars set to make their U.S. commercial debuts that year, as per the terms of the various settlement agreements between the drug makers.
“We believe that the introduction of biosimilars will improve the lives of patients, as well as contribute to the quality and economic sustainability of health care systems,” Thomas Seck, senior vice president of medicine and regulatory affairs at Boehringer Ingelheim, told Healio Rheumatology. “We are proud to be the company driving the advancement of biosimilars and delivering the first and only interchangeable biosimilar with Humira.”
The FDA approved Boehringer Ingelheim’s application for a supplemental biologics license for Cyltezo, officially deeming it interchangeable with Humira, on Oct. 15. 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.
To achieve an interchangeable designation, a biosimilar drug must undergo an interchangeable study of multiple substitutions in patients. The company producing the biosimilar must show how patients perform when they are switched back and forth multiple times from a reference product to the interchangeable biosimilar candidate.
In Cyltezo’s interchangeable study, the phase 3 randomized VOLTAIRE-X clinical trial, the drug demonstrated equivalence with Humira with no meaningful clinical differences in pharmacokinetics, efficacy, immunogenicity and safety between the switching and continuous treatment groups, according to Boehringer Ingelheim. The results of the trial were presented at the American Academy of Dermatology 2021 conference.
As an interchangeable biosimilar, it can be substituted by a pharmacist for the reference product, a practice commonly called “pharmacy-level substitution,” with individual state law governing how and whether the prescribing physician will be notified. According to the FDA, this can result in cost savings for the patient.
“As the first Interchangeable biosimilar of Humira, Cyltezo represents an important step toward bringing patients more affordable treatment options for complex, and often expensive, biologic reference products,” Martin Alan Menter, MD, chairman of the division of dermatology at Baylor University Medical Center, in Dallas, said in the Boehringer Ingelheim release. “This is incredibly important for patients, who can be confident that once available, citrate-free Cyltezo has the same efficacy and safety as the originator medicine with the added benefit of cost savings.”
Perspective
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David R. Fernandez, MD, PhD
The additional data supporting the ability to go back and forth between the biosimilar and originator could certainly help to allay some concerns among physicians about the efficacy and safety of biosimilars. Providers are constrained to a degree when choosing between biologic agents by insurers and pharmacy benefit managers, but these data may be compelling to those groups as well.
I think overall public interest in biosimilars will be impacted in a big way if use of biosimilars results in cost savings or ease of authorization that are felt at the level of the individual patient or prescriber – failing that, enthusiasm may remain limited.
Perspective
Back to TopMarcus Snow, MD, FACR
The American College of Rheumatology appreciates the work of the FDA to approve the first adalimumab interchangeable biologic. We strongly believe that safe and effective treatments should be available to patients at the lowest possible cost.
The competition that biosimilars bring to the biologic marketplace offers significant hope for reduction of drug costs if physicians and patients can be sufficiently reassured of their efficacy and safety through rigorous scientific study of these products. However, as always, the decision for the most appropriate treatment must remain between the provider and the patient. We hope this approval will both improve access to biologic medications and help drive down their costs.
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