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Etanercept News

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 Approves Eticovo (etanercept-ykro), a Biosimilar to Enbrel

INCHEON, Korea – As of April 2019 – Samsung Bioepis Co., Ltd. today announced that the US Food and Drug Administration (FDA) has approved Eticovo (etanercept-ykro), a biosimilar referencing Enbrel (et...

FDA Approves Expanded Use of Enbrel (etanercept) to Treat Children with Chronic Moderate-To-Severe Plaque Psoriasis

THOUSAND OAKS, Calif., Nov. 4, 2016 /PRNewswire/ – Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application...

FDA Approves Erelzi (etanercept-szzs), a Biosimilar to Enbrel

August 30, 2016 – The U.S. Food and Drug Administration today approved Erelzi, (etanercept-szzs) for multiple inflammatory diseases. Erelzi is a biosimilar to Enbrel (etanercept), which was...

FDA Medwatch Alert: Tumor Necrosis Factor (TNF) blockers, Azathioprine and/or Mercaptopurine: Update on Reports of Hepatosplenic T-Cell Lymphoma in Adolescents and Young Adults

  [UPDATED 11/04/2011]  Healthcare professionals should remain vigilant for cases of malignancy in patients treated with TNF blockers, and report such cases to MedWatch. The reports should include: p...

FDA Medwatch Alert: Tumor Necrosis Factor-alpha (TNFα) Blockers: Label Change - Boxed Warning Updated for Risk of Infection from Legionella and Listeria

including Remicade (infliximab), Enbrel (etanercept), Humira (adalimumab), Cimzia (certolizumab pegol), and Simponi (golimumab) ISSUE: FDA notified healthcare professionals that the Boxed Warning for...

FDA Medwatch Alert: Tumor Necrosis Factor (TNF) blockers, Azathioprine and/or Mercaptopurine: Update on Reports of Hepatosplenic T-Cell Lymphoma in Adolescents and Young Adults

[Posted 04/14/2011] ISSUE: FDA continues to receive reports of a rare cancer of white blood cells (known as Hepatosplenic T-Cell Lymphoma or HSTCL, primarily in adolescents and young adults being...

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Further information

Related condition support groups

Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Juvenile Rheumatoid Arthritis, Plaque Psoriasis, Alzheimer's Disease, Psoriasis

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Enbrel

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