Celltrion has expanded its presence in Europe’s biologic medicines market with the launch of Omlyclo 300 mg, an omalizumab biosimilar, adding a higher-dose option to its existing portfolio for patients with allergic asthma and chronic spontaneous urticaria. The South Korean biopharmaceutical company said the new strength is being introduced across European markets, with Germany, the UK and France among the first countries to receive supplies.
The launch broadens Celltrion’s commercial offering following the European introduction of Omlyclo 75 mg and 150 mg in late 2025. The company is now positioning the 300 mg presentation as another option for healthcare professionals and institutions managing patients who require omalizumab treatment. Celltrion said the rollout is expected to reach additional European countries progressively, with the company targeting completion across the region by the end of 2026.
The development comes as demand for biosimilars continues to shape competition in Europe’s biologic drug market. Omlyclo is Celltrion’s biosimilar version of omalizumab, the active ingredient in Xolair, and is the first anti-IgE antibody biosimilar approved by the European Commission. The broader portfolio gives Celltrion an opportunity to compete not only through product availability but also through different strengths and administration formats.
Omlyclo 300 mg Adds More Choice for European Patients and Providers
Celltrion is supplying the new 300 mg strength in two device formats: a pre-filled syringe and an autoinjector. The company said the availability of both presentations is intended to give patients and healthcare professionals greater choice depending on treatment circumstances and individual requirements.
The addition of multiple administration options is becoming increasingly relevant in the European pharmaceutical market, where convenience and treatment delivery can influence prescribing, procurement and patient experience. For healthcare institutions, having different device presentations available can also provide greater flexibility when establishing treatment protocols or managing patient populations.
Celltrion began introducing Omlyclo 300 mg in selected European markets around the middle of 2026. Germany, France and the UK are among the key markets where the rollout has started, while supply is being extended to other countries. The company expects the European launch to be completed by the end of the year.
Omlyclo is approved in the European Union for several indications. These include allergic asthma, chronic spontaneous urticaria and chronic rhinosinusitis with nasal polyps. The medicine works by targeting immunoglobulin E, or IgE, an antibody involved in allergic responses.
For Celltrion, the expanded dose range also strengthens the commercial position of Omlyclo as the company seeks to increase adoption in European markets. The company has highlighted its intention to compete for pharmaceutical tenders and maintain sales growth during the second half of 2026.
The European market is particularly important for biosimilar manufacturers because national healthcare systems and institutional procurement programs can create opportunities for lower-cost alternatives to established biologic therapies. However, competition remains intense, with manufacturers required to demonstrate reliable supply, regulatory compliance and commercial value in individual markets.
Celltrion’s strategy therefore extends beyond simply adding another dose. By offering 75 mg, 150 mg and 300 mg strengths alongside different delivery devices, the company is building a broader product proposition around a single active ingredient.
Celltrion Targets Wider Market Reach as Omlyclo Portfolio Grows
The latest launch reflects Celltrion’s wider strategy of expanding its biosimilar business in established pharmaceutical markets. The company has built its reputation around biologic medicines and has developed products spanning areas such as immunology, oncology, hematology, ophthalmology and endocrinology.
Omlyclo represents an important addition to that portfolio because omalizumab is used in the management of multiple chronic allergic and respiratory conditions. Celltrion has described the product as its first European Commission-approved anti-IgE antibody biosimilar, giving the company an early position in this segment of the European market.
The introduction of the 300 mg presentation could also help the company address a wider range of treatment requirements without relying on a single formulation. In markets where healthcare providers have different preferences for administration devices, offering both pre-filled syringes and autoinjectors may support broader adoption.
Celltrion’s European expansion also comes at a time when healthcare systems are under pressure to manage pharmaceutical spending while maintaining access to advanced therapies. Biosimilar medicines have become an important part of that discussion because they can introduce additional competition after reference biologics establish themselves in the market.
The company’s plans indicate that Europe will remain a major commercial focus for Omlyclo. Following the initial launches in Germany, France and the UK, Celltrion is gradually extending availability to other countries. Completing the rollout by the end of 2026 would give the company a wider geographic footprint for the product heading into 2027.
The next phase will likely depend on how effectively Celltrion converts regulatory approval and product availability into sustained demand. Tender outcomes, reimbursement conditions, physician familiarity and supply reliability will all influence the product’s performance across individual European markets.
For now, the launch of Omlyclo 300 mg gives Celltrion a broader platform from which to compete in Europe’s biologic medicines market. With additional dose strength and two delivery formats, the company is seeking to make its omalizumab offering more adaptable to healthcare providers while strengthening its position in the growing European biosimilar sector.
