Celltrion said that the Ministry of Food and Drug Safety has approved its investigational new drug (IND) application for a phase 3 clinical trial of CT-P39, a biosimilar for Xolair, which treats allergic asthma and chronic urticaria.

Xolair is an antibody biopharmaceutical sold by Genentech and Novartis, a blockbuster product with global sales of 3 trillion won ($3.3 billion) last year.

Celltrion plans to conduct the phase 3 trial at about 65 clinical trial institutions in seven countries, including in Korea, on 600 people with idiopathic urticaria. The company aims to demonstrate equivalence in efficacy and safety through comparative clinical trials between CT-P39 and Xolair and complete phase 3 clinical trials within the first half of 2023.

It also started a global phase 1 clinical trial for safety and pharmacokinetic evaluation in July last year. The firm has secured safety data from the intermediate results of phase 1 clinical trials. It is entering into phase 3 of this global clinical trial for a therapeutic confirmation test for approval.

“Celltrion is striving to expand the market share of Remsima SC, which has convenient patient administration, and other biosimilar products such as Truxima and Hezuma, while speeding up global clinical trials of additional biosimilars,” a company official said. “We will do our best to provide high-quality biopharmaceuticals at reasonable prices to patients around the world by successfully conducting phase 3 clinical trials of CT-P39.”