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Humira News
FDA Approves Simlandi (adalimumab-ryvk), an Interchangeable Biosimilar to Humira
REYKJAVIK, Iceland and PARSIPPANY, N.J., Feb. 24, 2024 (GLOBE NEWSWIRE) – Alvotech (NASDAQ: ALVO) and Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE:...
Updated FDA Labeling Recommendations for Biosimilar and Interchangeable Biosimilar Products
October 26, 2023 – Over the last eight years, FDA has approved more than 40 biosimilar products (biosimilars), and they have become an important treatment option for health care professionals and...
FDA Grants Interchangeable Designation to Pfizer’s Biosimilar Abrilada
NEW YORK, October 5, 2023 – Pfizer Inc. (NYSE: PFE) today announced that the U.S. Food and Drug Administration (FDA) has designated Abrilada™ (adalimumab-afzb) as an interchangeable biosimilar to Hum...
Treatment Effect of Tofacitinib, Adalimumab Compared in RA
WEDNESDAY, July 12, 2023 – For adults with rheumatoid arthritis (RA), there is a modest reduction in the mean Disease Activity Score in 28 joints using C-reactive protein (DAS28-CRP) at three months...
FDA Approves Yuflyma (adalimumab-aaty), a Biosimilar to Humira
JERSEY CITY, N.J.--(BUSINESS WIRE) May 24, 2023 --Celltrion USA today announced that the U.S. Food and Drug Administration (FDA) has approved Yuflyma® (adalimumab-aaty), a high-concentration ...
Humira (adalimumab) Receives FDA Approval to Treat Pediatric Patients Living with Moderately to Severely Active Ulcerative Colitis
NORTH CHICAGO, Ill., Feb. 24, 2021 /PRNewswire/ – AbbVie (NYSE: ABBV) today announced that the U.S. Food and Drug Administration (FDA) approved Humira (adalimumab) for the treatment of moderately to...
FDA Approves Hulio (adalimumab-fkjp), a Biosimilar to Humira
HERTFORDSHIRE, England and PITTSBURGH and TOKYO, July 9, 2020 /PRNewswire/ -- Mylan N.V. (NASDAQ: MYL) and Fujifilm Kyowa Kirin Biologics Co., Ltd. today announced that the U.S. Food and Drug Admini...
FDA Approves Abrilada (adalimumab-afzb), a Biosimilar to Humira
November 18, 2019 - Pfizer Inc. (NYSE: PFE) today announced the United States (U.S.) Food and Drug Administration (FDA) has approved Abrilada™ (adalimumab-afzb), as a biosimilar to Humira® (a...
FDA Approves Hadlima (adalimumab-bwwd), a Biosimilar to Humira
INCHEON, Korea – July 24, 2019 – Samsung Bioepis Co., Ltd. today announced that the U.S. Food and Drug Administration (FDA) has approved Hadlima (adalimumab-bwwd), a biosimilar referencing Humira (ad...
FDA Approves Hyrimoz (adalimumab-adaz), a Biosimilar to Humira
Holzkirchen, Germany, October 31, 2018 - Sandoz, a Novartis division and the pioneer and global leader in biosimilars, today announced that the US Food and Drug Administration (FDA) approved its...
FDA Approves Cyltezo (adalimumab-adbm), a Biosimilar to Humira
Ridgefield, Conn., August 29, 2017 – Boehringer Ingelheim Pharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) approved Cyltezo, a biosimilar to Humira, in a p...
FDA Approves Amjevita (adalimumab-atto), a Biosimilar to Humira
September 23, 2016 – The U.S. Food and Drug Administration today approved Amjevita (adalimumab-atto) as a biosimilar to Humira (adalimumab) for multiple inflammatory diseases. Amjevita is approved...
AbbVie's Humira (adalimumab) Receives FDA Approval to Treat Adults with Non-Infectious Intermediate, Posterior and Panuveitis
NORTH CHICAGO, Ill., June 30, 2016 /PRNewswire/ – AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved Humira...
FDA Approves Humira (adalimumab) for Moderate to Severe Hidradenitis Suppurativa
NORTH CHICAGO, Ill., Sept. 10, 2015 /PRNewswire/ – AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) approved Humira...
FDA Approves Humira (adalimumab) for the Treatment of Pediatric Patients with Crohn's Disease
NORTH CHICAGO, Ill., Sept. 25, 2014 /PRNewswire/ – AbbVie announced today that the U.S. Food and Drug Administration (FDA) has approved Humira (adalimumab) for reducing signs and symptoms, and...
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