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 ...

YUSIMRY™ (adalimumab-aqvh) - list price $995 per carton of two 40 mg/0.8 mL autoinjectorsSee https://www.yusimry.com for YUSIMRY™ Full Prescribing Information, including Boxed Warning and Medication ...

HADLIMA™ (adalimumab-bwwd) injection, 40 mg/0.4 mL & 40 mg/0.8 mL is now interchangeable with all high- and low-concentration presentations (autoinjector, prefilled syringe, and single-dose vial) of ...

AbbVie Receives Orphan Drug Designation for HUMIRA(R) (adalimumab) from the U.S. Food and Drug Administration for the Investigational Treatment of Certain Forms of Non-infectious Uveitis NORTH CHICAGO ...

--Samsung Bioepis Co., Ltd. and Organon& Co. today announced that the U.S. Food and Drug Administration has accepted for review the Supplemental Biologics License Application for the ...

Nov. 9, 2004 — The U.S. Food and Drug Administration (FDA) and Abbott Laboratories have warned healthcare professionals via letter of warnings added to the labeling for tumor necrosis factor ...

- Orphan Drug Designation program provides orphan status to medications intended for the safe and effective treatment, diagnosis or prevention of rare diseases - HS, a chronic, immune-mediated skin ...

Samsung Bioepis Co., Ltd. and Organon & Co. (NYSE: OGN) today announced that the US Food and Drug Administration (FDA) has designated the HADLIMA™ (adalimumab-bwwd) high- and low-concentration (40 ...

“This designation is meaningful as it signifies our continued commitment to making biosimilars more accessible. Both biosimilars and interchangeable biosimilars are highly similar and have no ...

NORTH CHICAGO, Ill., May 20, 2014 /PRNewswire/ --AbbVie (NYSE:ABBV) announced today that the U.S. Food and Drug Administration (FDA) has granted HUMIRA® (adalimumab) orphan drug designation for the ...