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Phase I/IIb trial of CT-P6 shows comparability to trastuzumab Posted 12/04/2013

Results of a phase I/IIb trial for South Korean biotechnology company Celltrion’s biosimilar candidate CT‑P6 were presented at the 13th St Gallen International Breast Cancer Conference held in St Gallen, Switzerland, on 13–16 March 2013. The results demonstrated the comparable pharmacokinetics and safety of CT-P6 to the reference drug.

CT-P6 is intended to be a biosimilar of Roche’s breast cancer blockbuster Herceptin (trastuzumab). Herceptin is a HER2+ breast cancer therapy designed to treat aggressive HER positive metastatic and adjuvant breast cancer.

The double-blind, randomized phase I/IIb study was carried out at the Samsung Medical Center in Seoul, South Korea. A total of 174 female patients aged 18 or over having HER2+ over-expression and an ECOG (Eastern Cooperative Oncology Group) score of 0 or 1 (where 0 denotes perfect health and 5 death) were included in the study. The primary aim of the study was to compare the pharmacokinetic profile of CT-P6 with that of trastuzumab, as well as evaluating the efficacy and overall safety of both treatments.

The results demonstrated an equivalent pharmacokinetic profile for CT-P6 compared to trastuzumab. The biosimilar candidate was also well tolerated and had a safety profile comparable to that of trastuzumab.

Celltrion has already had its first monoclonal antibody, Remsima (infliximab), approved by the Korean Food and Drug Administration and has applied to EMA for approval of the drug [1, 2].

Celltrion has an agreement to develop and market eight biosimilars, including infliximab, with US-based generics major Hospira [3]. The company has at least six other biosimilars in various stages of development, covering indications such as breast cancer, Hodgkin’s lymphoma, colorectal cancer, colon cancer and respiratory syncytial virus.

The company is also carrying out a phase III trial in Romania with CT-P6 to compare the biosimilar candidate to trastuzumab with the aim of demonstrating comparable efficacy and safety.

Editor’s comment
It should be noted that comparative bioavailability studies do not prove ‘bioequivalence’. They merely find or fail to find statistically significant differences in drug exposure with a given degree of statistical probability; usually only in a small number of normal healthy volunteers, and often without looking at food effects.

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References

1.  GaBI Online - Generics and Biosimilars Initiative. Biosimilar monoclonal antibody approved in Korea [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Apr 12]. Available from: www.gabionline.net/Biosimilars/News/Biosimilar-monoclonal-antibody-approved-in-Korea

2.  GaBI Online - Generics and Biosimilars Initiative. EMA reviews its first biosimilar monoclonal antibody [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Apr 12]. Available from: www.gabionline.net/Biosimilars/News/EMA-reviews-its-first-biosimilar-monoclonal-antibody

3.  GaBI Online - Generics and Biosimilars Initiative. South Korea to emerge as global leader in biosimilar R & D [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Apr 12]. Available from: www.gabionline.net/Biosimilars/News/South-Korea-to-emerge-as-global-leader-in-biosimilar-R-D

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Source: ClinTrials.gov

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