Biosimilars in the United States: Current Status and Future Implications

Biosimilars in the United States: Current Status and Future Implications

October 18, 2021
3 min read
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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 FDA has made 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. Source: Adobe Stock.

“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.

Janet Woodcock

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.”