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Adalimumab News

US Food and Drug Administration (FDA) Grants Interchangeability Designation to Samsung Bioepis and Organon Hadlima (adalimumab-bwwd) Injection

INCHEON, Korea & JERSEY CITY, N.J.--(BUSINESS WIRE) May 27, 2025 – Samsung Bioepis Co., Ltd. and Organon & Co. (NYSE: OGN) today announced that the US Food and Drug Administration (FDA) has...

Celltrion's Yuflyma (adalimumab-aaty) Receives FDA Interchangeability Designation for All Approved Dosage Forms and Strengths

INCHEON, South Korea, May 23, 2025 /PRNewswire/ – Celltrion, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted an expanded interchangeable designation for Yu...

Data Suggests TNF Inhibitors Help Prevent Serious Complications in Children with Crohn's Disease

FRIDAY, Dec. 27, 2024 A specific class of anti-inflammatory drugs can help children avoid a debilitating complication of Crohn’s disease. A new study published recently in the journal Gut shows c...

Select Strengths of Sandoz Biosimilar Hyrimoz Granted Interchangeability by FDA

May 08, 2024 – On April 5, 2024, the US Food and Drug Administration (FDA) approved Sandoz’s supplemental biologics license application (sBLA) seeking interchangeability to include the 10 mg/0.1 mL, ...

US FDA Approves High-Concentration, Citrate-Free Formulation of Cyltezo (adalimumab-adbm) injection

RIDGEFIELD, Conn., May 1, 2024 /PRNewswire/ – Boehringer Ingelheim announced today that the U.S. Food and Drug Administration (FDA) has approved the high-concentration, citrate-free formulation of ...

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:...

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...

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 ...

US FDA Approves the Cyltezo Pen, a New Autoinjector Option, Ahead of July 1 Commercial Launch

RIDGEFIELD, Conn., May 22, 2023 /PRNewswire/ -- Boehringer Ingelheim announced today that the U.S. Food and Drug Administration (FDA) has approved the Cyltezo® Pen, a new autoinjector option for ...

Sandoz Receives US FDA Approval for Biosimilar Hyrimoz (adalimumab-adaz) High-Concentration Formulation

Biosimilar Hyrimoz® (adalimumab-adaz) high-concentration formulation (HCF) approved for seven indications of reference medicine Humira®* With this approval, Sandoz adalimumab HCF biosimilar will o...

FDA Approves Yusimry (adalimumab-aqvh), a Biosimilar to Humira

REDWOOD CITY, Calif., Dec. 20, 2021 (GLOBE NEWSWIRE) – Coherus BioSciences, Inc. (Nasdaq: “CHRS”, “the Company”, “Coherus”) announced that the United States Food and Drug Administration (“FDA”) appro...

FDA Approves Yusimry (adalimumab-aqvh), a Biosimilar to Humira

REDWOOD CITY, Calif., Dec. 20, 2021 (GLOBE NEWSWIRE) – Coherus BioSciences, Inc. (Nasdaq: “CHRS”, “the Company”, “Coherus”) announced that the United States Food and Drug Administration (“FDA”) appro...

U.S. FDA Approves Cyltezo (adalimumab-adbm) as First Interchangeable Biosimilar to Humira

Regulatory approval for Interchangeability was supported by positive data from Boehringer Ingelheim’s Phase III randomized VOLTAIRE-X clinical trial Data showed that switching several times b...

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...

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