Samsung Bioepis "Biosimilar Anticancer Drug, Equivalence Confirmed in Interim Results"

[Asia Economy Reporter Choi Dae-yeol] Samsung Bioepis revealed additional research results on the anticancer drug Aybintio (Avastin biosimilar, generic name Bevacizumab), recently launched in Europe, at the European Society for Medical Oncology (ESMO Virtual Congress 2020), held over five days starting on the 14th (local time).

Previously, the company announced the global Phase 3 clinical trial results of this treatment at last year's event, and this year, after additional analysis, it gathered data that further proves clinical equivalence with the original drug. The company conducted a comparative analysis between Aybintio and the original drug on 665 non-small cell lung cancer patients classified as the per-protocol population who adhered to the clinical trial protocol during the Phase 3 trial.

First, data from weeks 11 and 17, where significant treatment progress could be confirmed in the highest overall response rate over 24 weeks, were analyzed. The highest overall response rate refers to the proportion of patients whose tumors shrank beyond a predetermined range within a specific period. The analysis showed that the risk difference in the highest overall response rate between Aybintio and the original drug at weeks 11 and 17 was 2.2% and 2.4%, respectively, indicating no significant difference between the two drugs.

When examining the maximum percentage change in tumor size compared to baseline, no significant difference was found. This represents the average of the greatest tumor reduction rates at each week from the start of treatment. A company official stated, "Through follow-up clinical studies, we have once again demonstrated that the medical efficacy of Aybintio is at the same level as that of the original drug."

Aybintio is a treatment drug that received marketing authorization from the European Union Commission last month and is the first Avastin biosimilar developed domestically. Avastin, sold by the multinational pharmaceutical company Roche, is used in Europe to treat metastatic colorectal cancer, non-small cell lung cancer, metastatic breast cancer, and other tumor diseases. Its annual sales last year reached 8.5 trillion KRW, with 2.2 trillion KRW generated within Europe alone. Samsung Bioepis has established a sales network for Aybintio in five major European countries, including Germany, in partnership with local partner MSD.

This content was produced with the assistance of AI translation services.