BRIEF—Celltrion launches additional doses for Yuflyma in USA

South Korea-based Celltrion’s US subsidiary says it has now launched an 80mg dose of Yuflyma (adalimumab-aaty), a high-concentration (100mg/mL) and citrate-free formulation of AbbVie’s Humira biosimilar, in the USA.

Yuflyma is currently available in a single 40mg dose in both a prefilled syringe with safety guard and autoinjector. The addition of an 80mg dose will offer more choice and dosage flexibility for patients and clinical practices.

More than 80% of patients treated with Humira in the USA rely on a high-concentration and citrate-free formulation.

It also maintains stability at 25℃ (77°F) for 31 days, with protection from light, and is a latex-free device.

“Yuflyma demonstrated a comparable efficacy, safety, pharmacokinetics, and immunogenicity profile as the reference product,” said Thomas Nusbickel, chief commercial officer at Celltrion USA.

“These new dose amounts and the auto-injector option provide flexible regimens. These new dose amount and the 2 step auto-injector option provide flexibility and convenient self-administration,” he noted.