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Adalimumab-aaty was FDA approved on May 23, 2023, and became commercially available in the US on July 2, 2023.
Adalimumab-aaty (Celltrion USA), a Humira biosimilar, has been added to the Costco member prescription program, allowing eligible members and their dependents to obtain the drug at a substantial discount.1
"We are pleased to partner with Costco, the largest warehouse club and third-largest retailer in America," Francine Galante, Vice President, Market Access, Celltrion USA, said in a statement.1 "We are committed to increasing patient choice through access to biosimilars. The inclusion of adalimumab-aaty to the Costco Member Prescription Program will expand patients' treatment options and help reduce healthcare costs."
Adalimumab-aaty is an FDA-approved, high-concentration, citrate-free biosimilar to reference adalimumab (Humira) and is approved for the same indications as reference adalimumab: rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA), psoriatic arthritis, ankylosing spondylitis, Crohn disease (CD), ulcerative colitis (UC), plaque psoriasis, hidradenitis suppurativa, and uveitis, althoughfor pediatric patients, adalimumab-aaty is only approved for treating JIA and CD.
"Celltrion is well positioned for continued growth in the U.S. market, which will increase competition and, ultimately, access to high-quality biosimilars and biologic products at a reduced cost," Tom Nusbickel, Chief Commercial Officer, Celltrion USA, added.1 "To further enhance patient access, we are increasing our manufacturing capacity and strengthening our supply chain resilience to ensure delivery of patient treatment."
Adalimumab, a TNF inhibitor, was originally approved by the FDA for treating RA in 2002 and racked up additional approved indications up until its latest approval for pediatric UC in 2021.2 The first biosimilar approved was adalimumab-atto, approved in late 2016. Approvals of other biosimilars followed, with the latest approval of adalimumab-ryvk in early 2024.3 However, adalimumab biosimilarsonly started to become available with a highly anticipated launch in 2023 due to patent litigation by AbbVie.4 Adalimumab-aaty specifically was first approved by the FDA on May 23, 2023, and became commercially available in the US on July 2, 2023.1
Ten biosimilars have now been launched in the United States, most of which are citrate free and high concentrations injections that either come in a prefilled pen, a prefilled syringe, or a vial. Despite last year’s mass launch, adalimumab biosimilars are still not widely used across the US, with the healthcare system missing out on billions of dollars of savings, as adalimumab is the bestselling pharmaceutical of all time.4
Of these biosimilars, only adalimumab-adbm, adalimumab-ryvk, and adalimumab-afzb are currently considered interchangeable with reference adalimumab.3 Gaining additional interchangeable designations for the biosimilars may improve uptake, as may garnering additional pediatric approvals, although barriers still remain with insurance coverage and physician prescription.