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