Celltrion Healthcare presents positive results for biosimilar rituximab candidate CT-P10

December 6, 2016 10:23 AM

New data presented at the 2016 American Society of Hematology (ASH) Annual Meeting demonstrate that CT-P10 (biosimilar rituximab candidate) and reference rituximab are equivalent in terms of pharmacokinetics (PK) in patients with advanced follicular lymphoma (AFL), a form of non-Hodgkin lymphoma.

A total of 121 AFL patients were enrolled in a 1:1 ratio (59 patients on CT-P10 and 62 patients on reference rituximab) to demonstrate PK similarity of CT-P10 to reference rituximab, each given in combination with standard chemotherapy of cyclophosphamide, vincristine, and prednisone (CVP). The results from the randomized, double-blind, controlled study found equivalent PK and similar pharmacodynamics (PD), immunogenicity and safety profiles of CT-P10 to those of reference rituximab for up to 12 weeks.

This evidence of similarity builds on clinical experience of CT-P10 along with the data in patients with rheumatoid arthritis (RA), which shows compelling similarity in PK, PD, efficacy, safety and immunogenicity and was presented at the 2016 American College of Rheumatology (ACR) Annual Meeting and the Annual European Congress of Rheumatology (EULAR).

Dr. Bertrand Coiffier, the global principle investigator of the AFL study, Head of the Department of Hematology at Hospices Civils de Lyon and Professor at the University Claude Bernard, Lyon, France, said: “The results presented today show similar PK and comparable B cell kinetics, immunogenicity and safety profiles between CT-P10 biosimilar rituximab and reference rituximab in patients with AFL, confirming comparable results in clinical studies in patients with RA. The overall program provides substantial and convincing evidence for similarity between CT-P10 and reference rituximab.

“The availability of CT-P10 biosimilar rituximab for treatment of patients with lymphoproliferative disorders is expected to reduce costs of treatment, potentially enabling more patients to initiate rituximab treatment not only through induction but also maintenance and consolidation phases of treatment.”

Man Hoon Kim, President and CEO of Celltrion Healthcare, said: “Based on the totality of evidence collected from our global clinical programme, we believe that CT-P10 is a cost-effective alternative to the reference product. It could improve patient access and ultimately reduce the cost of rituximab use across autoimmune and oncology indications in many countries throughout the world.”

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