Celltrion's Omlyclo gets EU nod as first Xolair biosimilar

(Celltrion)

 

Korean biosimilar giant Celltrion announced Thursday that its anti-IgE antibody biosimilar Omlyclo has been approved in Europe, after a series of clinical trials with the reference product Novartis' Xolair.

Omlyclo, also called by project name CT-P39, received formal product approval from the European Commission on Tuesday, approximately two months after receiving the initial approval recommendation from the Committee for Medicinal Products for Human Use under the European Medicines Agency.

Omlyclo became the first Xolair biosimilar and a first-mover product to gain official approval in Europe, thereby securing a competitive advantage in the market.

Xolair is an injectable medication that is used to treat asthma, as well as nasal polyps and chronic idiopathic urticaria, or itchy rash.

"With our major products already holding a significant market share in Europe, Omlyclo is expected to fully benefit from the first-mover advantage due to the established infrastructure in the market," a Celltrion official said.

"Given the substantial lead over our competitors, we will rapidly increase our market share based on this advantage and strive to provide patients with high-quality treatment options at reasonable prices."

Celltrion demonstrated the efficacy and equivalence of CT-P39 to the original drug in a global phase 3 clinical trial involving 619 patients with chronic spontaneous urticaria across six European countries, confirming its similarity in terms of safety.

The reference drug, Xolair, is an antibody biopharmaceutical used to treat allergic asthma, chronic rhinosinusitis with nasal polyps and chronic idiopathic urticaria. As of 2023, it generated approximately 5 trillion won ($3.8 billion) in global sales. The market is expected to expand further with the recent approval of additional food allergy indications for Xolair in the United States.

Celltrion anticipates strengthening its competitiveness in major global markets by expanding its product portfolio to include treatments for various diseases, such as autoimmune disorders and cancers, leveraging the European approval of Omlyclo.

Omlyclo is Celltrion’s sixth biosimilar, joining Remsima SC, a subcutaneous formulation of infliximab, which is approved for use in the EU, along with Remsima, Truxima, Herzuma, Yuflyma and Vegzelma. Omlyclo is currently under review by the US Food and Drug Administration following its submission in March.

Meanwhile, Celltrion plans to continue its product development and investment, aiming to expand its biosimilar portfolio to 11 products by 2025, in addition to the six that are already commercialized. By 2030, the company aims to secure 22 products and achieve an annual sales target of 12 trillion won.

By Kim Hae-yeon(hykim@heraldcorp.com)