September 08, 2024

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[THE INVESTOR] Celltrion said on June 5 its copy version of Roche’s Herceptin for patients with early breast cancer works as well as the original drug in late-stage trials.

The drug, Herzuma, also known as CT-P6, was tested on patients with early breast cancer and HER2 overexpression 1 in the phase 3, double-blind, randomized, parallel-group studies. After surgery, patients received Hezuma to complete a one-year treatment.

Celltrion’s biosimilar measured up against the reference product in both the primary endpoint of pathological complete response -- 46.8 percent for Herzuma and 50.4 percent for Herceptin -- and secondary endpoints of overall response rate, pharmacokinetics, pharmacodynamics and safety.

The data was presented at the 2017 American Society of Clinical Oncology Annual Meeting in Chicago, US, on June 4.

“It’s encouraging to see that the data shows comparability between CT-P6 and the reference trastuzumab and that we were able to demonstrate therapeutic equivalence between the two,” said Justin Stebbing, professor of cancer medicine and oncology, Imperial College London.

The study adds to an increasing wealth of data available for biosimilars in oncology. Herzuma is the second product in Celltrion’s oncological biosimilar portfolio, which has been submitted to the European Medicine Agency for approval in all indications of the reference trastuzumab including HER2-positive breast cancer and HER2-positive metastatic stomach cancer.

Celltrion currently sells Remsima, a biosimilar version of Johnson & Johnson‘s Remicade and Truxima, referencing Roche’s Rituximab in Europe.

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