Celltrion said Friday that Omlyclo, its biosimilar referencing Genentech and Novartis' Xolair (omalizumab), has received approval to become the first biosimilar of its kind in Europe.

This approval comes two months after the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended its authorization on March 21.

Genentech and Novartis developed Xolair to treat allergic asthma, chronic rhinosinusitis with nasal polyposis, and chronic idiopathic urticaria.

A blockbuster product with global sales of about $3.9 billion in 2022, the substance patent has already expired, and the formulation patent is set to expire in Europe in March 2024 and the U.S. in November 2025.

Omlyclo's formal marketing authorization by the European Commission makes it the first Xolair biosimilar to gain approval in Europe, positioning it as a first mover in the market. The company expects the milestone to give Celltrion a competitive edge in the continent.

Celltrion said the company plans to enhance its product portfolio, including treatments for autoimmune diseases and cancer, by adding allergy treatments.

The approval follows successful global phase 3 clinical trials involving 619 patients with chronic spontaneous urticaria across six European countries. The trials demonstrated that CT-P39 is equivalent in efficacy and similar in safety to the original Xolair medication.

"With our major products already holding significant market share in Europe, the approval of Omlyclo as the first Xolair biosimilar will allow us to leverage our existing infrastructure and maximize the first mover advantage," a company official said. "We intend to rapidly expand our market share and ensure patients can access high-quality treatments at reasonable prices."