Celltrion's anticancer biosimilar passes Phase 3 clinical trials

Celltrion logo

Phase 3 clinical trials of CT-P16, Celltrion's biosimilar of anticancer drug Avastin, produced significant results proving its safety and efficacy, the company announced Wednesday.

The drug is an identical copy of bevacizumab, better known as Avastin, the name it is marketed under by Switzerland’s Roche. It is used to treat metastatic colorectal cancer, metastatic breast cancer, non-small cell lung cancer and glioblastoma.

Biosimilars, according to the U.S. Food and Drug Administration (FDA), are biological products that are approved based on proof that they are highly similar to other FDA-approved products. The drugs have no clinically significant differences in terms of safety or effectiveness from the reference product, but they cost less.

The trials were conducted on a total of 689 non-small cell lung cancer patients, half of which were administrated with CT-P16 and the other half with Avastin.

The company then was able to produce results that statistically prove its equivalence with the original drug in terms of efficacy. The results were first announced during an annual meeting of the American Association for Cancer Research, the world’s first and largest non-profit cancer research organization dedicated to preventing and curing all types of cancer.

Following the results, Celltrion applied to get the biosimilar product approved for use in Korea, Europe and the United States. If approved, it will be Celltrion’s third anticancer biosimilar after Truxima, for blood cancers, and Herzuma, which targets stomach and breast cancers.

The Avastin patent expired in July 2019 in the United States and in January 2022 for most parts of Europe. Avastin generated 4 trillion won ($3.3 billion) in global sales in 2021.

BY SARAH CHEA [chea.sarah@joongang.co.kr]