The US Food and Drug Administration (FDA) has approved the biosimilar adalimumab-aaty (Yuflyma) in a highly concentrated citrate-free formulation, the manufacturer, Celltrion USA, announced today. It is the ninth biosimilar of adalimumab (Humira) to be approved in the United States.
Yuflyma is approved for the treatment of adult patients with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis, plaque psoriasis and hidradenitis suppurativa. It is also approved for polyarticular juvenile idiopathic arthritis for patients 2 years of age and older, as well as Crohn\’s disease in adults and pediatric patients 6 years of age and older.
The formulation was approved based on a comprehensive data package of analytical, preclinical and clinical studies, according to Celltrion USA, “demonstrating that Yuflyma is comparable to the reference product Humira in terms of efficacy, safety, pharmacokinetics and immunogenicity up to 24 weeks and 1 year after treatment.\”
The FDA also conducted a double-blind, randomized Phase 3 study comparing switching from reference adalimumab to Yuflyma versus continuing on reference adalimumab or Yuflyma for patients with active rheumatoid arthritis. In that study, the efficacy, pharmacokinetics, safety, and immunogenicity of Yuflyma and reference adalimumab were comparable after 1 year of treatment, even after switching from reference adalimumab to Yuflyma.
“Currently, more than 80 percent of Humira-treated patients in the United States rely on a high-concentration, citrate-free formulation of this drug. The availability of a high-concentration, citrate-free formulation biosimilar adalimumab provides an important treatment option for patients with inflammatory diseases who benefit from this effective therapy,\” said Jonathan Kay, MD, of the University of Massachusetts, Worcester, in the news release.
The citrate-free formulation is believed to lead to less pain during injection.
Yuflyma will be available in pre-filled syringe and auto-injector delivery options.
Celltrion USA expects to market the drug in the United States in July 2023. Following the initial launch of 40 mg/0.4 mL, Celltrion USA plans to launch 80 mg/0.8 mL and 20 mg/0.2 mL dosage forms ml.
The company is also seeking an interchangeability designation from the FDA following the completion of an interchangeability study of 366 patients with chronic plaque psoriasis. The interchangeability designation would mean that patients successfully switched from Humira to Yuflyma multiple times during the study. The interchangeability designation would allow pharmacists to automatically substitute Humira for Yuflyma. In these cases, individual state laws control how and if doctors will be notified of this step.
If interchangeability is approved for Yuflyma, which the company tentatively expects in the fourth quarter of 2024, it would be only the third FDA-approved interchangeable biosimilar overall and the second adalimumab biosimilar to be designated as such, after adalimumab-adbm (Cyltezo) in the October 2021.
Yuflyma was approved in Canada in December 2021 for 10 indications: rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn\’s disease, adult ulcerative colitis, hidradenitis suppurativa, plaque psoriasis, uveitis of adult and pediatric uveitis.
In February 2022, the European Commission granted marketing authorization for Yuflyma for these 10 indications, as well as for non-radiographic axial spondyloarthritis, pediatric plaque psoriasis and pediatric Crohn\’s disease.
In April 2022, Celltrion USA signed a licensing deal with AbbVie, the maker of Humira. Under this agreement, Celltrion USA will pay royalties to AbbVie on sales of its individual biosimilars, and AbbVie has agreed to drop all patent litigation.
Full prescribing information for Yuflyma is available here.
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