April 24, 2024

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[THE INVESTOR] Celltrion Healthcare said on June 16 new clinical data proved its biosimilar Truxima to be fully comparable to its reference medication, Roche’s Rituxan, in terms of efficacy and safety for both oncology and autoimmune disease indications.

The data from final phase 3 studies on 140 patients with advanced follicular lymphoma -- a form of non-Hodgkin lymphoma -- showed that Truxima, or CT-P10, was not inferior in terms of efficacy compared to Rituxan, when each were given a combination with the standard chemotherapy of cyclophosphamide, vincristine and prednisone.

 

Celltrion booth at the International Conference on Malignant Lymphoma

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The findings were presented at the International Conference on Malignant Lymphoma and the European League Against Rheumatism Congress 2017, held in Lugano, Switzerland, on June 14.

“We are the only company to date to have successfully conducted phase 3 clinical trials reviewing the safety and efficacy of biosimilar in two indications -- rheumatoid arthritis and non-Hodgkin’s lymphoma -- a testament to our commitment to provide quality biosimilar treatments for patients supported by robust clinical data,” said Kwon Hyuk-chan, medical director of Celltrion Healthcare.

Truxima was granted approval from the European Medicines Agency for all indications treated by the original drug including non-Hodgkin’s lymphoma and chronic lymphocytic leukemia, as well as autoimmune disorders in February.

Celltrion plans to submit an application to the US Food and Drug Administration for sales approval later this year. The findings from the study also showed that the safety profile, pharmacokinetics, pharmacodynamics and immunogenicity of CT-P10 were comparable to those of reference Rituximab.

The findings showing comparable long-term efficacy and safety between CT-P10 and Rixutan in rheumatoid arthritis patients treated over a period of 48 weeks were also presented at the European rheumatism congress.

“The data presented add to the increasing wealth of evidence for biosimilar rituximab demonstrating that CT-P10 was non-inferior in terms of efficacy and comparable in pharmacokinetics and safety to the reference drug for patients with advanced stage follicular lymphoma,” Bertrand Coiffier, Head of the Department of Hematology at Hospices Civils de Lyon, France, said.

By Park Han-na (hnpark@heraldcorp.com)