The US Food and Drug Administration (FDA) has designated Celltrion’s Yuflyma (adalimumab-aaty) as an interchangeable biosimilar to AbbVie’s Humira (adalimumab).
The decision allows Yuflyma to be substituted for Humira at pharmacies without the intervention of a prescribing healthcare provider, depending on state laws.
Yuflyma is approved in the US for rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa and uveitis.
The high-concentration, citrate-free biosimilar is currently available as a 20mg, 40mg and 80mg solution for injection in a prefilled syringe and auto-injector pen.
A biosimilar, according to the FDA, is a biological medicine that is highly similar to one already approved in the US. This means patients can expect the same safety and effectiveness from the biosimilar as they would from the reference product, but may potentially benefit from lower healthcare costs.
The regulator’s latest decision on Yuflyma was based on data from a late-stage interchangeability study in patients with moderate-to-severe active plaque psoriasis.
Results showed similar pharmacokinetics, efficacy, safety and immunogenicity outcomes in patients who were treated continuously with reference adalimumab and those who alternated between reference adalimumab and Yuflyma during the dosing interval of week 25 to 27.
Celltrion USA’s chief commercial officer, Thomas Nusbickel, said the new designation further positions Yuflyma “to help more patients gain access to and afford the therapy they need”.
“Yuflyma has the same dosage form, route of administration and dosing regimen as the reference product,” explained Nusbickel. “The pharmacist’s ability to substitute the biosimilar directly at the pharmacy without the hassle of a new prescription and without the patient having to learn a new method of administration can be a game changer in increasing patient access to adalimumab.”
The designation comes less than two weeks after the FDA approved Celltrion’s biosimilars referencing Amgen’s bone disease therapy denosumab. The regulator approved Stoboclo (CT-P41, denosumab-bmwo) and Osenvelt (CT-P41, denosumab-bmwo) for all indications covered by Amgen’s Prolia and Xgeva, respectively.
Nusbickel said the authorisation marked “another step forward in [Celltrion’s] efforts to deliver cost-effective and high-quality treatments that address critical unmet needs in osteoporosis-related fracture as well as cancer-related skeletal events”.