Celltrion accelerates Europe rollout of Xolair biosimilar

Celltrion is accelerating its European market expansion for Omlyclo, a biosimilar referencing Novartis’ Xolair, after completing launches in major markets including Germany, Spain, the U.K., and France.

Omlyclo is an antibody biopharmaceutical with the same composition as the original drug, Novartis' Xolair, which has indications that include allergic asthma, chronic spontaneous urticaria, and chronic rhinosinusitis with nasal polyps. Xolair recorded approximately 6 trillion won ($4.1 billion) in global sales in 2024.

The product, which received European Medicines Agency approval in May last year as the first omalizumab biosimilar to secure authorization in Europe, was initially introduced in Norway in September and has since continued sequential rollouts across the region.

The company said Omlyclo is pursuing a first-mover advantage in Europe by securing early adoption through direct distribution and competitive tender strategies tailored to national market structures.

Celltrion recorded a significant milestone in the Netherlands, where the European Medicines Agency headquarters is located, winning multiple hospital tenders immediately upon launch.

According to Celltrion, the contracted supply volume represents about 70 percent of the entire omalizumab market in the Netherlands.

Celltrion plans to continue expanding Omlyclo’s availability across Europe, focusing on customized go-to-market models according to each country’s procurement environment. In tender-driven markets such as Spain and the U.K., where no competing omalizumab biosimilar is currently available, the company aims to leverage its first-mover position to secure early competitive advantage.

In retail-based markets, including Germany, Celltrion intends to increase awareness through targeted marketing and engagement activities with physicians, pharmacists, and distribution channels.

These strategies are already showing results, with some markets placing advance orders before formal tender processes begin, reflecting growing anticipation and faster-than-expected adoption.

“Omlyclo is the first omalizumab biosimilar to launch in Europe, and we are expanding our market impact based on proven quality, efficacy, and safety data,” Celltrion Senior Vice President and Head of Europe Ha Tae-hun said. “With the trust we have built through our direct sales network in Europe, we will continue expanding launch territories to support greater treatment access for patients and strengthen our position in the European market.”