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 ...
The safety and efficacy of Humira in patients with moderate to severe fingernail psoriasis and moderate to severe chronic plaque psoriasis was evaluated in a Phase 3, multicenter, double-blind, ...
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 ...
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 ...
TOKYO, Sept 27, 2021 - (JCN Newswire) - - AbbVie GK, Eisai Co., Ltd., and EA Pharma Co., Ltd announced today the additional approval for a high- dose regimen in adult patients with ulcerative colitis ...
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 ...
INCHEON, South Korea, May 22, 2025 /PRNewswire/ -- Celltrion, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted an expanded interchangeable designation for YUFLYMA ® ...
Credit: Getty Images. Amjevita is supplied as a 40mg/0.8mL single-dose prefilled SureClick autoinjector, and as 20mg/0.4mL and 40mg/0.8mL single-dose prefilled syringes. The Food and Drug ...