Multiple strengths and device options could strengthen Omlyclo’s position in hospital tenders and accelerate commercial growth
Celltrion is expanding the 300mg formulation of its omalizumab biosimilar Omlyclo across major European markets, a move that could help the South Korean biopharmaceutical company convert its first-mover advantage into a stronger commercial position as competition in Europe’s omalizumab biosimilar market begins to emerge.
The company has launched Omlyclo 300mg in Germany, the United Kingdom and France following the European rollout of its 75mg and 150mg formulations late last year. Celltrion plans to gradually expand the 300mg formulation across Europe by the end of 2026.
The significance of the launch extends beyond adding another dosage strength. With 75mg, 150mg and 300mg options, combined with pre-filled syringe and autoinjector presentations, Celltrion is building a broader product portfolio designed to address the different needs of patients, healthcare professionals and procurement institutions.
That could become increasingly important as the European omalizumab biosimilar market moves from an early-entry phase toward greater competition.
From First-Mover Status to Market Execution
Omlyclo became the first omalizumab biosimilar approved by the European Commission in May 2024, referencing Xolair. Celltrion subsequently began its European commercial rollout in 2025, establishing an early presence ahead of potential biosimilar competitors.
The market environment, however, is beginning to change. A second omalizumab biosimilar has since been licensed in Europe, while other developers are advancing competing candidates through regulatory processes.
For Celltrion, this means the strategic question is shifting from whether it can enter the market first to how effectively it can translate that head start into prescriptions, tender wins and sustained market share.
The 300mg rollout provides another tool in that strategy.
Patients requiring a 300mg dose can receive the medication in a single injection rather than using two 150mg injections. The higher-dose formulation therefore has the potential to reduce injection burden while simplifying treatment for both patients and healthcare providers.
Celltrion is also offering the 300mg strength in both pre-filled syringe and autoinjector formats, giving healthcare professionals greater flexibility depending on the treatment setting and patient requirements.
Portfolio Breadth Could Matter in European Tenders
The competitive advantage of biosimilars in Europe increasingly involves more than price alone.
Supply reliability, dosage options, device selection, storage requirements and ease of administration can influence procurement decisions and product adoption, particularly as multiple suppliers compete for institutional contracts.
Celltrion is positioning Omlyclo around these factors.
The company says the product can be stored refrigerated at 2°C to 8°C for up to two years and at room temperature of up to 25°C for as long as seven days. Its ability to be returned to refrigerated storage after temporary room-temperature exposure could also provide greater flexibility across distribution and clinical settings.
Combined with the expanded dosage and device portfolio, these characteristics give Celltrion several points of differentiation as it competes for European tenders.
The 300mg formulation also extends a regulatory strategy that has been developing across multiple markets. The European Commission approved the additional 300mg line extension in November 2025, while the high-dose formulation has also secured approvals in markets including the United States and Canada.
The Next Test Is Commercial Growth
For Celltrion, the next phase of Omlyclo’s European expansion will ultimately be measured by commercial execution.
The company intends to use the expanded portfolio to pursue additional tenders across major European countries and begin supplying volumes secured through successful bids during the second half of the year.
The timing could be important. Establishing physician familiarity, procurement relationships and supply networks before additional competitors gain scale could help Celltrion preserve some of the benefits created by its early market entry.
Omlyclo therefore represents more than another biosimilar launch for the company. It is becoming a test of Celltrion’s broader strategy of combining early entry with formulation diversification and direct commercial execution to build durable positions in increasingly competitive biosimilar markets.
“The launch of Omlyclo 300mg allows us to offer patients and healthcare professionals more convenient and flexible treatment options,” said Taehun Ha, Senior Vice President and Head of Europe at Celltrion.
“Building on the first omalizumab biosimilar advantage and broad product portfolio, we will continue to strengthen our competitive position in key tenders and work to sustain Omlyclo’s strong growth momentum across Europe throughout the second half.”
