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February 28, 2020

Celltrion presents Truxima’s results of phase 3 clinical trials in US forum

PUBLISHED : December 09, 2019 - 14:36

UPDATED : December 09, 2019 - 14:38

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Celltrion announced on Dec. 9 that it has disclosed its biosimilar Truxima’s results of phase 3 clinical trial at the 2019 annual meeting of the American Society of Hematology last week.

“The clinical trials were conducted among patients in European countries including Germany, Spain and Russia as well as Asian countries like Japan for 40 months,” a Celltrion official said in a statement. 




More than 17,000 experts of blood diseases from over 100 countries attended the meeting in Florida.

The company gave a presentation showing that Truxima was not inferior in terms of efficacy and safety for patients suffering advanced follicular lymphoma -- a form of non-Hodgkin lymphoma -- compared to its original drug Rituxan, developed by Swiss pharmaceutical giant Roche Holding.

The data was from conducting the clinical trials among 140 patients each with both Truxima and Rituxan.

According to the findings, patients’ overall survival rate four years after receiving Truxima and Rituxan treatment was estimated to be around 88 percent and 93.3 percent respectively. The biosimilar’s progression-free survival rate -- length of time during and after the treatment of a disease -- was 60.9 percent, while Rituxan’s rate was 54.7 percent.

The company also noted that its biosimilar’s time to progression -- length of time from the start of treatment until the disease starts to get worse -- was also similar to the original drug.

In November last year, Celltrion received marketing authorization from the US Food and Drug Administration for Truxima and is currently selling the drug with its partner TEVA in the US. It was the first biosimilar based on Rituxan to be approved by the US health regulator.

By Song Seung-hyun (ssh@heraldcorp.com)

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