Omriclo, a treatment for chronic spontaneous urticaria and allergic asthma. [Celltrion]
Omriclo, a treatment for chronic spontaneous urticaria and allergic asthma. [Celltrion]

Celltrion has launched the 300mg formulation of Omriclo (omalizumab), its treatment for chronic spontaneous urticaria and allergic asthma, in major European markets, accelerating its push to lock in a first-mover advantage.

The company announced Tuesday that it had introduced the high-dose 300mg product in Germany, the United Kingdom and France, following the launch of the 75mg and 150mg strengths in Europe late last year.

Celltrion said it is expanding supply of the 300mg formulation in countries where Omriclo is already available and plans to roll it out sequentially across the rest of Europe. The company aims to build market share quickly by broadening its supply chain ahead of the originator drug, which is currently available in only some European countries.

The 300mg launch significantly improves convenience for patients and prescribing flexibility for clinicians. Patients requiring a 300mg dose previously needed two separate 150mg injections; the new single-dose formulation reduces that to one. Celltrion is also supplying both a prefilled syringe and an auto-injector, giving patients and healthcare providers a wider choice of administration options to suit individual needs.

Storage stability and ease of use have also been enhanced. Omriclo can be kept under refrigeration (2–8 degrees Celsius) for up to two years and at room temperature (up to 25 degrees Celsius) for up to seven days — a longer shelf life than the originator. The product also supports re-refrigeration after exposure to room temperature, maximizing flexibility throughout the distribution and storage process.

The 300mg launch is expected to sharpen Celltrion's competitiveness in European public tenders and accelerate its biosimilar prescription share, combining a high-dose single formulation, multiple device options and differentiated storage stability.

Ha Tae-hoon, head of Celltrion's European operations, said the launch would allow the company to offer patients and clinicians more convenient and varied treatment options. "We will sustain our edge in major-market tender competitions on the strength of our first-mover advantage and broad product lineup, and continue to deliver strong growth across Europe in the second half," he said.


silverpaper@heraldcorp.com