Celltrion Healthcare has presented new data demonstrating that the efficacy and safety of CT-P10 is comparable to reference rituximab in patients with advanced follicular lymphoma (AFL) over two years.
The efficacy and safety of CT-P10 was evaluated in a randomised, double-blind, phase III study which evaluated the overall survival (OS), progression-free survival (PFS), and sustained response in comparison to the reference biologic rituxan.
The results showed that at the median follow-up duration of 23 months, the updated efficacy data in AFL patients demonstrated comparable OS and PFS.
In terms of sustained response, the proportion of patients who showed relapse or disease progression after achieving overall response was 19.4% (in the CT-P10 group and 21.3% in the reference rituximab group.
CT-P10 was also well-tolerated and its safety profile including immunogenicity of CT-P10 was comparable to that of reference rituximab over 23 months of treatment.
HoUng Kim, Head of Strategy and Operations Division, Celltrion Healthcare, said: “The two-year study marks another significant milestone for Celltrion Healthcare, showing that CT-P10 is comparable to reference rituximab in terms of overall survival and progression-free survival.
“Now that the CT-P10 is approved in the US, the availability of the first rituximab biosimilar has the potential to significantly improve access to rituximab for patients with non-Hodgkin’s lymphoma indications.
“As a cost-effective alternative to the reference product, CT-P10 will reduce the burden on healthcare systems resulting in better patient outcomes.”
CT-P10 is the first rituximab biosimilar to be approved in the United States.