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Celltrion’s Biosimilar Rituximab First In Line For FDA Review

 
• By Jung Won Shin

After launching its biosimilar infliximab Inflectra in the US late last year, Celltrion is targeting a leading position in oncology in the US with its biosimilar rituximab emerging as the first to be accepted for review by the US FDA.

Celltrion Headquarters

The US FDA has accepted for review Celltrion Inc..’s BLA for CT-P10, a proposed monoclonal antibody biosimilar to Roche ’s Rituxan (rituximab), placing it well ahead of competition, currently in late stages of development.

According to Datamonitor Healthcare's analyst Hristina Ivanova, CT-P10, also known as Truxima, is expected to be the first rituximab biosimilar...

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