Development of Xolair biosimilars is in full swing

Allergic asthma and chronic urticaria treatment, patent expiration in 2 years

Celltrion, Teva from the U.K., etc., Celltrion is the first one

Xolair (Novartis)

Domestic and foreign bio companies have started to develop Xolair (Omalizumab) biosimilars which patents expire in two years.

 

The development stage of Celltrion, a domestic company, is the fastest.

 

According to Clinical Trials, a clinical registration site of the NIH on the 17th, six clinical trials of Xolair biosimilars are currently registered.

 

Three companies, Celltrion, Theba in the UK, and CSPC in China, are conducting phase 3 clinical trials, while three are in phase 1 clinical trials, including Zhejiang Huahai Pharmaceutical in China, Generium in Russia, and Syneos Health in the United States.

 

Xolair is a treatment for allergic asthma and chronic urticaria.

 

It was jointly developed by Genentech and Novartis, subsidiaries of Roche.

 

Based on the two companies' earnings announcements, Xolair's sales last year amounted to 4.2 trillion won, up 10.5% from the previous year.

 

Xolair will be challenged by biosimilars from 2024.

 

Xolair patents expire in Europe in 2024 and in the United States in 2025, respectively.

 

Celltrion is analyzed as the fastest place to develop Xolair biosimilars.

 

Celltrion is conducting phase 3 clinical trials of the Xolair biosimilar CT-P39.

 

The end of the clinical trial is expected to be January next year.

 

Considering the period of the European licensing process, it is expected that biosimilars will be released in time for Xolair's patent expiration.

 

Teva, a British pharmaceutical company, is closely chasing this.

 

Teva is conducting phase 3 clinical trials of the Xolair biosimilar TEV-45779.

 

However, the end of the clinical trial is expected to be June 2024, later than Celltrion.

 

China's CSPC entered phase 3 clinical trials of the Xolair biosimilar SYN008 earlier than Teva, but it is still in the pre-patient recruitment stage.

 

In addition, Generium's GNR-044 has ended phase 1 clinical trials, while Zhejiang Huahai Pharmaceutical's HS632 and Synos' BP11 are undergoing phase 1 clinical trials.

 

Due to the clinical progress of companies, Celltrion is likely to take over the first mover of Xolair biosimilars.

 

First mover is considered a top priority when evaluating the competitiveness of biosimilars.

 

This is because biosimilars generate profits by bringing the market share of the original market.

 

Celltrion's biosimilars Remsima and Truxima, which were released as first movers, are prominent in the European market.

 

According to Celltrion, as of the third quarter of last year, the European market share was 54% for Remsima and 34% for Truxima.