The US Food and Drug Administration (FDA) has designated Celltrion’s Yuflyma (adalimumab-aaty) as an interchangeable biosimilar to AbbVie’s Humira (adalimumab).

Yuflyma is approved in the US for plaque psoriasis, hidradenitis suppurativa and other inflammatory conditions.

The decision allows Yuflyma to be substituted for Humira at pharmacies without the intervention of a prescribing healthcare provider, depending on state laws.

“The pharmacist’s ability to substitute the biosimilar... 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,” explained Celltrion USA’s chief commercial officer, Thomas Nusbickel.

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.

The FDA’s latest decision 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.