South Korea’s biopharmaceutical firm Celltrion Inc. has proved again that its anticancer biosimilars Truxima and Herzuma are as safe and effective as their reference drugs during their clinical trials, a move that is expected to help the Korea’s leading autoimmune biosimilar producer advance into the anticancer drug market.

Celltrion on Saturday (local time) presented the results of clinical trials comparing the efficacy of self-developed copy drug Truxima to the original reference Rituximab on patients with progressive follicular lymphoma, a type of blood cancer, at the American Society of Hematology (ASH) meeting in Atlanta at a hematology meeting in the United States.

According to Celltrion, it carried out trials on 121 patients with follicular lymphoma and prescribed them with either biosimilar Truxima or its original reference by different clinical factors such as gender, age, progression of disease, and ethnicity. The result of the trials demonstrated that the Celltrion’s copycat drug is equivalent to the original drug in terms of pharmacokinetics, said the Korean biotechnology company.

A day earlier, Celltrion also presented the results of a clinical study into cardiotoxicity in early stage breast cancer patients that received treatment for a year with either Celltrion’s another anticancer biosimilar Herzuma or its original reference at the San Antonio Breast Cancer Symposium in the U.S.

Researchers studied and analyzed 549 female patients aged over 18 who have been injected with copycat Herzuma or the original drug before and after operation for early stage breast cancer. Celltrion reaffirmed safety of Herzuma after finding out that only about 1 percent of patients in both groups suffered from a drop in ejection fraction in the left ventricle and from toxic reaction in their heart functions.

An unnamed official from Celltrion said that the latest presentation material of its clinical studies will be used as key data supporting quality reliability and higher prescription rate of biosimilars in the U.S. and medical communities in other regions.

The company expects the latest results would eventually help it expand its presence in the anticancer biosimilar market. Celltrion already received marketing approval for Truxima from the European Medicines Agency (EMA) in February this year and launched sales in the United Kingdom in April. It is also awaiting for marketing approval of Herzuma from the EMA after it filed an application in October, last year. Celltrion also filed an application with the U.S. Food and Drug Administration for Truxima and Herzuma in the second quarter of this year.

By Shin Chan-ok and Lee Eun-joo

[ⓒ Pulse by Maeil Business News Korea & mk.co.kr, All rights reserved]