The designation allows pharmacists to substitute it for Humira without prescriber approval (per state law), which expands ...

Organon and Samsung Bioepis' HADLIMA granted FDA interchangeability designation approval for all high- and-low concentration presentations.

The approval for interchangeability was supported by data from a phase 4 trial that assessed the pharmacokinetics, efficacy, safety, and immunogenicity of Hadlima vs Humira in patients with moderate ...

YUFLYMA® (adalimumab-aaty) is a high-concentration (100mg/mL) and citrate-free formulation of Humira® (adalimumab) biosimilar ...

at the sale price of $1,038 per carton containing two pre-filled pens or syringes. This is, according to the two companies, an 85% discount on Humira’s list price. Also on Saturday, Sandoz ...

It is the ninth Humira biosimilar approved by the FDA ... 40 mg and 80 mg solution for injection in both a prefilled syringe and autoinjector pen.

such as autoinjectors and prefilled syringes. The FDA’s designation, which allows pharmacists to substitute HADLIMA™ for Humira® without prescriber consultation according to state pharmacy ...

Yuflyma is a high-concentration (100mg/ml) and citrate-free formulation of Humira biosimilar ... 40 mg and 80 mg solution for injection in a prefilled syringe and in an autoinjector pen.

“With this approval, pharmacies can substitute HADLIMA for the reference product Humira without consulting ... formulation of prefilled syringe and autoinjector. The high-concentration (40 ...

YUFLYMA is a high-concentration, citrate-free biosimilar to Humira, approved for multiple ... and 80mg solution for injection in prefilled syringes and as 40mg and 80mg in autoinjectors.

INCHEON, South Korea, May 23, 2025 /PRNewswire/ -- Celltrion, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted an expanded interchangeable designation for YUFLYMA ® ...