The expanded interchangeability now applies to the 40mg prefilled syringe and the 40mg and 80mg autoinjectors, in addition to the 20mg and 80mg prefilled syringes. The Food and Drug Administration ...

Credit: Celltrion. Yuflyma, a tumor necrosis factor blocker, was approved in May 2023 as a biosimilar to Humira. Similar PK, efficacy, safety, and immunogenicity data were observed between the ...

The Food and Drug Administration has granted an expanded interchangeable designation for Celltrion’s Yuflyma (adalimumab-aaty), now including prefilled syringe (40mg) and autoinjectors (40mg and 80mg) ...

Fresenius Kabi has obtained the Food and Drug Administration’s permission for its citrate-free adalimumab biosimilar Idacio for use in the treatment of chronic autoimmune diseases for all eligible ...

Please provide your email address to receive an email when new articles are posted on . Hadlima was approved as a biosimilar to Humira in 2019. The drug is available in a pre-filled syringe or a ...

Amjevita is supplied as a 40 mg/0.8 mL single-dose prefilled SureClick autoinjector, and as 20 mg/0.4 mL and 40 mg/0.8 mL single-dose prefilled syringes. Amjevita ™ (adalimumab-atto), a citrate-free ...

The US Food and Drug Administration (FDA) has approved the biosimilar adalimumab-aaty (Yuflyma) in a citrate-free, high-concentration formulation, the manufacturer, Celltrion USA, announced today. It ...

In the last month, the FDA has granted interchangeability status to additional adalimumab biosimilars. Biosimilars with an interchangeable designation may be substituted for the reference product at ...

Autoinjector recognized by the Arthritis Foundation with Ease of Use Certification Individualized patient support program “HADLIMA For You” available including co-pay support Designed to improve ...

AbbVie GK, Eisai Co., Ltd., and its subsidiary EA Pharma Co., Ltd. announced the additional approval for a new dosing regimen of Humira Pre-filled Syringe 40 mg/0.8 ml for Subcutaneous Injection ...

Please provide your email address to receive an email when new articles are posted on . The FDA has approved a citrate-free, 100 mg/mL formulation of the Humira biosimilar Hadlima, according to a ...

Autoinjector recognized by the Arthritis Foundation with Ease of Use Certification Individualized patient support program “HADLIMA For You” available including co-pay support Designed to improve ...