Celltrion Launches 300 mg Omlyclo Omalizumab Biosimilar Across Key European Markets

25 August 2026 | Tuesday | News


New 300 mg strength rolls out in Germany, UK and France in pre-filled syringe and autoinjector formats, with Celltrion targeting wider European availability by year-end.

  • Omlyclo® (omalizumab) 300 mg launched in key European markets including Germany, the UK and France, with rollout to expand across Europe by year-end
  • Omlyclo® 300 mg strength available in both pre-filled syringe (PFS) and autoinjector (AI) presentations
  • Multiple dose strengths and device options broaden treatment flexibility for healthcare professionals

Celltrion (announced the launch of the 300 mg strength of Omlyclo® (omalizumab), a treatment for chronic spontaneous urticaria and allergic asthma, in Europe.1 With the addition of the 300 mg strength, Celltrion has expanded its Omlyclo® portfolio to include multiple dose strengths and device presentations for patients, healthcare professionals and healthcare institutions.

The launch of Omlyclo® 300 mg allows us to offer patients and healthcare professionals more convenient and flexible treatment options

Following the European launch of Omlyclo® 75 mg and 150 mg late last year, Celltrion began rolling out the 300 mg strength in key markets including Germany, the UK and France in the middle of this year. Celltrion is gradually expanding supply to other European countries and plans to complete the rollout across Europe by the end of the year.

Celltrion is offering Omlyclo® 300 mg in both pre-filled syringe (PFS) and autoinjector (AI) presentations, allowing patients and healthcare professionals a choice of device depending on the treatment setting and individual patient needs. This comprehensive portfolio provides greater flexibility in dose strengths and device options.

Celltrion will continue to provide product information to healthcare professionals and institutions as part of its commercial activities across Europe.

“The launch of Omlyclo® 300 mg 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 biosimilar1 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.”

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