[THE INVESTOR] Korea’s Celltrion said on Sept. 11 that its biosimilar candidate Herzuma has shown therapeutic comparability to reference Roche’s Herceptin in early-stage breast cancer patients in phase 3 clinical trials.

The study involving 549 patients with human epidermal growth factor receptor 2, or HER2,-positive early breast cancer investigated the efficacy and safety of Herzuma compared to Herceptin as a pre-operative and post-operative stages of treatment over one year since June 2014. 

“Data showing therapeutic comparability post-surgery is a significant milestone in boosting physician confidence in this biosimilar as it indicates that Herzuma can be an effective treatment option for women with early breast cancer and HER2 overexpression both pre- and post-operation,” said Justin Stebbing, professor of cancer medicine and oncology, Imperial College London.

Herzima is Celltrion’s third biosimilar product seeking to enter Europe following Remsima and Truxima. The company filed an application for marketing approval with the European Medicines Agency in October last year. With global sales of around US$7 billion a year, Herceptin is one of the trio of big-selling Roche drugs.

Results from the neoadjuvant stage of the study revealed that the total pathological complete response rate during surgery was 46.8 percent for Herzuma and 50.4 percent for reference Herceptin, which are within the predefined equivalence margin.

Data based on the adjuvant treatment period of the study showcased at the European Society for Medical Oncology 2017, shows that the proportion of patients who underwent breast conservation surgery was similar between both therapies.

“It adds to the increasing wealth of data supporting Herzuma as a biosimilar for Herceptin. It highlights Celltrion’s commitment to delivering affordable medicines through our growing oncology biosimilar portfolio,” Celltrion Healthcare CEO Kim Man-hoon said.

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