Celltrion Confirms Biosimilarity of Xolair Biosimilar

Celltrion Healthcare shared preliminary data from a phase 3 clinical trial demonstrating that its omalizumab biosimilar (CT-P39) is comparable in safety and efficacy to the reference product (Xolair) in patients with chronic spontaneous urticaria, according to a report from the Korea Herald.

Xolair (Genentech and Novartis) is used to treat allergic asthma, chronic urticaria (hives), and nasal polyps. Global sales of the drug amounted to $3.8 billion in 2022.

The phase 3 study lasting 40 weeks is still underway; The latest results were collected 24 weeks into the study. The study included 619 participants with chronic spontaneous urticaria from 6 countries, including Bulgaria and Poland. Patients were randomized to receive 300 mg injections of the biosimilar or the reference product.

So far, CT-P39 showed to be statistically equivalent to Xolair and resulted in the same biological response in terms of efficacy, safety, immunogenicity, and pharmacokinetics, with the results meeting the pre-defined equivalence criteria. The primary endpoint is change from baseline to week 12 in the weekly itch severity score, also known as the ISS7.

Celltrion noted that it plans to apply for regulatory approval for CT-P39 both in the Republic of Korea, where the company is headquartered, and abroad after the completion of the study. The company said that it expects to complete the study on June 30.

Outside of Celltrion, Shanghai Tayin Biotechnology, Selexis with Generium, Glenmark, and Alvotech with BiosanaPharma are working on their own omalizumab biosimilar candidates.

Other Celltrion Products

In addition to CT-P39, Celltrion is awaiting regulatory approval from the FDA regarding its adalimumab biosimilar (Yuflyma). The drug is anticipated to launch on the US market in July 2023. The approval is expected in May 2023, according to Korea Biomedical Review.

Yuflyma has been approved for the Korean market and markets in the European Union. Celltrion also has biosimilars for Remicade (infliximab), Rituxan (rituximab), and Herceptin (trastuzumab). These products (Remsima, Truxima, and Herzuma, respectively) have all been approved for the European Union, the Republic of Korea, and the United States markets. Additionally, Celltrion has a biobetter of Remsima, which is the only subcutaneous infliximab product in the world.

Celltrion is also running phase 3 studies for its biosimilars referencing Prolia/Xgeva (denosumab), Stelara (ustekinumab), Eylea (aflibercept), and Actemra (tocilizumab). Denosumab is used to treat osteoporosis and prevent bone loss. Ustekinumab is used in the treatment of psoriasis, Crohn disease, and ulcerative colitis, and aflibercept is used to treat ophthalmic conditions. Tocilizumab is a treatment for rheumatoid arthritis.