Celltrion’s Truxima (rituximab-abbs) Receives FDA’s Approval for Three on-Hodgkin’s Lymphoma Indications

 Celltrion’s Truxima (rituximab-abbs) Receives FDA’s Approval for Three on-Hodgkin’s Lymphoma Indications

Celltrion’s Truxima (rituximab-abbs) Receives FDA’s Approval for Three on-Hodgkin’s Lymphoma Indications

Shots:

  • The approval is based on non-inferiority data demonstrating biosimilarity in pharmacology, immunogenicity, clinical efficacy with safety, potency and purity when compared to reference medicine (rituxan)
  • Truxima is a mAb, indicated and approved in three indications i.e. r/r, low-grade or follicular, CD20-positive, B-cell NHL, 1L patients with CD20-positive B-cell NHL and 1L Non-progressing low-grade CD20-positive B-cell NHL
  • The P.I involves a box warning with intake of Truxima can cause fatal infusion, severe mucocutaneous rxns, H2V reactivation and progressive multifocal leukoencephalopathy. In 2016, Celltrion and Teva collaborated for commercialization of Truxima in the US and Canada

 Click here read full press release/ article | Ref: Kyowa Kirin | Image: Korea Times

Vartika Singh

Vartika Singh is a content writer who loves to write research articles and reports at PharmaShots. She has in-depth knowledge of the life sciences industry including the Pharma and Biotech sectors. Any articles written by her can be contacted at connect@pharmashots.com.

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