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Truxima Approval History

Reviewed by J.Stewart BPharm Last updated on Nov 28, 2018.

FDA Approved: Yes (First approved November 28, 2018)
Brand name: Truxima
Generic name: rituximab-abbs
Dosage form: Injection
Company: Celltrion, Inc.
Treatment for: Non-Hodgkin's Lymphoma

Truxima (rituximab-abbs) is a CD20-directed cytolytic antibody biosimilar to Rituxan indicated for the treatment of adult patients with non-Hodgkin’s lymphoma.

  • The product label for Truxima contains a Boxed Warning to alert health care professionals and patients about the increased risk of fatal infusion reactions, severe skin and mouth reactions, Hepatitis B virus reactivation and Progressive Multifocal Leukoencephalopathy.
  • The FDA approval of Truxima is based on clinical data that demonstrates Truxima is biosimilar to Rituxan.
  • Truxima is administered as an intravenous infusion by a healthcare professional with appropriate medical support to manage severe infusion reactions that may occur.
  • Most common side effects reported in clinical trials were infusion reactions, fever, lymphopenia, chills, infection and asthenia.

Development History and FDA Approval Process for Truxima

DateArticle
Nov 28, 2018Approval FDA Approves Truxima (rituximab-abbs), a Biosimilar to Rituxan

Further information

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