On January 17, 2024, Celltrion announced the U.S. launch of a new, 80 mg/0.8 ml dosage strength of its HUMIRA® biosimilar, YUFLYMA® (adalimumab-aaty). As we previously reported, Celltrion received FDA approval for an 80 mg/0.8 ml dose and a 20 mg/0.2 ml dose on October 4, 2023. Celltrion's January 2024 announcement indicates that it expects the 20 mg version of YUFLYMA® "to be available in pharmacies in late Q1 2024."

YUFLYMA® is also currently sold as a 40 mg dose, following FDA approval for that dosage strength in May 2023 and U.S. launch in July 2023. Celltrion's announcement indicates that the new 80 mg product will be offered "at the same price as YUFLYMA 40 mg."

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Molly Grammel
Goodwin Procter LLP
The New York Times Building
620 Eighth Avenue
New York
NY 10018
Tel: 212813 8800
E-mail: rmertz@goodwinlaw.com
URL: www.goodwinlaw.com

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