Participants at the American Society of Hematology take a close look at a bulletin on Celltrion’s clinical trial during the ASH conference held on Saturday. [Photo by Celltrion]
Korea’s Celltrion shared the result of the world’s first head-to-head study comparing its antibody biosimilar Truxima (rituximab, project name CT-P10)) and its reference drug for patients with follicular lymphoma, a blood cancer, during a poster session of American Society of Hematology (ASH) annual meeting in San Diego on Saturday.
Truxima is an antibody biosimilar with active ingredient of rituximab used for the treatment of patients with non-hodgkin lymphoma and rheumatoid arthritis. Celltrion received marketing approval of Truxima from Korea’s health authorities in November and is waiting for approval from the European Medicines Agency (EMA).
"The bioequivalence of Truxima to the original drug was confirmed in terms of pharmacokinetics, pharmacodynamics, immunogenicity and safety through clinical studies on patients with not only rheumatoid arthritis and but also follicular lymphoma. Going forward, patients with non-hodgkin lymphoma will be more benefited from prescription of Truxima,” said professor Bertrand Coiffier of University Lyon 1, France, a participant in the study and a well-known expert in blood cancer biology.
Celltrion said the study drew attention from ASH participants as it marks the first clinical study of a biosimilar in patients with blood cancer. The company also said about one third of European patients prescribed with rituximab have follicular lymphoma and it expects the study data to serve as the key for the future leadership of Truxima in the rituximab biosimilar market.
By Shin Chan-ok
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