Celltrion’s Xolair biosimilar CT-P39 was given the Korean drug authority’s green light to proceed to a clinical phase 3 trial in Korea, the company said Thursday.

The company plans to begin the late stage human test of the pipeline first in Korea, and expand to 600 patients suffering from chronic spontaneous urticaria in seven countries.

So far, in Australia, Celltrion has gained midterm data for the drug’s safety in the human body from the phase 1 clinical trial that is being carried out there.

The global clinical phase 3 trial will be finalized in 2023, Celltrion said.

CT-P39 is a protein replicate of the blockbuster allergy treatment Xolair (omalizumab) that aims to become a more affordable alternative for allergic asthma and chronic spontaneous urticaria.

Xolair, marketed by Genentech and Novartis, is a drug highly in demand that raked in global annual revenue of 3.9 trillion won ($3.37 billion) in 2019.

Unlike novel drug development that starts from a base of zero, CT-P39 as a biosimilar has only to prove its similarity to Xolair in order to receive approval for market distribution.

By Lim Jeong-yeo (kaylalim@heraldcorp.com)