Celltrion gets FDA nod for Keytruda copy's phase 3 clinical trials

Celltrion Inc., South Korea’s biosimilar giant, will proceed with phase 3 trials for global blockbuster drug Keytruda’s copycat CT-P51, a treatment for non-small cell lung cancer, after obtaining approval from the US Food & Drug Administration, the company announced on Monday.

The Kospi-listed stock closed up 2% at 200,000 won ($145.93) on the same day on expectations for the diversification of Celltrion’s biosimilar lineup if the clinical trials succeed and the new biosimilar hits the market.

The Korean biosimilar giant has rolled out six lucrative copycats globally, including Remsima, Truxima and Herzuma, since its inception in 2002.

The six medicines' global sales reached 2.1 trillion won in 2023, accounting for nearly all of Celltrion’s total sales of 2.2 trillion won.

It also has five biosimilars in the pipeline and targets a portfolio of 11 copycat drugs by 2025 and 22 by 2030.

Biosimilars are products that demonstrate similar efficacy and safety to the original medicines but their prices are cheaper than the originators' reference products.

Following the FDA’s approval, Celltrion will carry out phase 3 trials of CT-P51 on 606 non-small cell lung cancer patients for two years.

The Korean company will prove the efficacy and safety of the biosimilar against the original medicine Keytruda, or pembrolizumab.

Keytruda is a blockbuster immunotherapy treatment indicated for non-small cell lung cancer and various other types of tumors, including skin cancer, bladder and urinary tract cancer, rectal cancer and more.

It was developed by US drug giant Merck & Co., known as Merck Sharp & Dohme (MSD) in other parts of the world.

Keytruda’s global sales hit $25 billion in 2023, becoming the world’s best-selling medicine.

Its patent will run out in the US in 2028 and in Europe in 2031, opening the door to biosimilars. 

In June Celltrion applied for FDA approval for CT-P51's phase 3 clinical trials.

Write to Dae-Kyu Ahn at powerzanic@hankyung.com

Sookyung Seo edited this article.