Herzuma, Celltrion’s antibody biosimilar used to treat breast and gastric cancer, has proved efficiency and safety equal to those of the original drug made by Roche, officials at the Korean company said Sunday.

Herzuma received approval from the Ministry of Food and Drug Safety for Herzuma in 2014 and applied to the European Medicines Agency for the right to sell in European markets last October.

The company presented phase 3 clinical trial study results to the American Society of Clinical Oncology conference held in Chicago Sunday, while publishing test results in the Lancet Oncology, an international medical journal, on the same day.

It conducted the research in 22 countries, including France and Italy, involving 549 patients with HER-2 positive early-stage breast cancer, starting in 2014. The study compared the total pathological complete response rate in two groups: a group taking either Celltrion’s drug or the original drug versus a group taking the combination of Docetaxel and FEC (combination of 5-Flurouracil, Epirubicin, Cyclophosphamide).

The trial found the Herzuma group had a total pathological complete response rate of 46.8 percent, while the control group had 50.4 percent, proving near equal effectiveness. Herzuma also had nearly the same breast pathological complete response rate, breast conservation rate, and overall response rate in comparison to the original drug.

The study also proved Herzuma fared as well as Herceptin regarding cardiac toxicity and immunogenicity, company officials said.

"It’s very encouraging to see clinical data demonstrating equivalence between Herzuma and the original drug," said Professor Justin Stebbing of the Imperial College London, Department of Surgery & Cancer and the leading author of Herzuma studies published in the Lancet Oncology. "We hope to contribute to lessening the financial burden of medical care by providing our high-quality breast cancer biosimilar Herzuma at a lower cost.”

A company official backed him up. “Celltrion has published a wealth of clinical data to demonstrate equivalence with the original product compared with other Herceptin biosimilar competing for products at this conference,” the official said. "We designed the study based on the guidelines of the advanced regulatory bodies and found remarkable results that provide trust for prescribing the drug in the medical community.”

The company is preparing a variety of strategies to capture the U.S. and European markets, including securing long-term clinical data for Herzuma and planning for other concomitant therapies, he added.

yjc@docdocdoc.co.kr

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