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Celltrion confirms safety, efficacy of Xolair biosimilar

By Yu Ji-soo

Published : April 10, 2023 - 15:26

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(Celltrion) (Celltrion)

South Korean drugmaker Celltrion confirmed the safety and efficacy of its biosimilar version of Xolair, which treats asthma and urticaria, in a phase 3 clinical trial, the firm said on Monday.

CT-P39 references Xolair, or omalizumab, a therapy jointly developed by global biotech company Genentech and healthcare company Novartis.

Xolair is mainly used to treat allergic asthma and chronic urticaria, or hives, as well as nasal polyps. Global sales of the medication reached approximately 5 trillion won ($3.8 billion) last year, according to Celltrion.

The phase 3 study, a 40-week clinical trial conducted by Celltrion, compares the efficacy and safety of CT-P39 versus Xolair in patients with chronic spontaneous urticaria.

The latest results -- collected 24 weeks into the study -- showed that CT-P39 is statistically equivalent to Xolair, yielding the same biological response in terms of efficacy, safety, immunogenicity and pharmacokinetics. This was determined based on the change in the Weekly Itch Severity Score, or ISS7, starting from the beginning of the trial period up to week 12.

The drugmaker also mentioned plans to apply for regulatory approval of its biosimilar both domestically and abroad after completing the phase 3 study. The company expects to wrap up the study on June 30.

“We will continue expanding our portfolio to include high-quality products for various conditions such as allergies and ophthalmologic diseases,” the pharmaceutical firm said.