Mabtas (rituximab biosimilar) / Intas 
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  • ||||||||||  Rituxan (rituximab) / Biogen, Zenyaku Kogyo, Roche
    Clinical, Review, Journal:  Regulatory Approval Scenario of Biosimilars in Pediatric Patients in the United States and European Union. (Pubmed Central) -  Oct 30, 2021   
    In the EU, pediatric assessments were not required for biosimilars; hence, all biosimilars (except rituximab) have been approved for the same indications as those of the reference biologics. Biosimilar developers need to be aware of the possible requirement of a pediatric study plan, development of pediatric drug delivery devices, and requirement of human factor studies for a device, to avoid delay in approval of biosimilars in the USA.