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

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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

  Ref: Kyowa Kirin | Image:Celltrion

 

Click here to­ read the full press release 

Tuba

Tuba was Senior Editor at PharmaShots. She was curious, creative, and passionate about recent updates and innovations in the life sciences industry. She covered Biopharma, MedTech, and Digital health segments. Tuba also had an experience in digital and social media marketing and ran the campaigns independently. She can be contacted at connect@pharmashots.com.

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