Ensuring familiarity with the area
Pharmacy teams and clinicians planning to use omalizumab biosimilar should prepare carefully. Read the following to understand where omalizumab is currently recommended for use.
National guidelines
Ensure you are familiar with:
- Omalizumab for treating severe persistent allergic asthma (NICE TA278)
- Omalizumab for previously treated chronic spontaneous urticaria (NICE TA339)
Where NICE has recommended the reference product (‘the originator’), the same advice will apply to the biosimilar medicine.
Product characteristics
Xolair (Novartis) is the omalizumab reference product. Xolair is currently licensed and recommended for use by NICE for:
- severe persistent allergic asthma in adults, adolescents and children (aged 6 years and over)
- chronic spontaneous urticaria in adults and adolescents (aged 12 years and over)
Xolair is licensed for chronic rhinosinusitis with nasal polyps but is not routinely commissioned for this indication; as Novartis did not provide an evidence submission to NICE.
Xolair preparations
Xolair is available as:
Note: the 75mg strength is not licensed for chronic spontaneous urticaria.
Incoming changes with omalizumab
Xolair lost patent exclusivity on the 8th September 2025. Meaning biosimilar omalizumab can now be marketed for all reference product indications. For further information on patents and loss of exclusivity see our articles on Understanding biosimilar and generic market entry (SPS page).
NHS Contract
The Medicines Procurement and Supply Chain web catalogue provides information about the products that are available on NHS contracts in England.
Licensed products
One omalizumab biosimilar (Omlyclo; Celltrion) is currently licensed by the MHRA for the same indications as the reference product (Xolair). Marketed products include:
A 300mg strength product may become available later in 2026.
Biosimilars under assessment
As of September 2025, we are aware the MHRA is assessing one omalizumab biosimilar; brand name currently unknown:
- AVT23;ADL018 (Alvotech; Advanz) – filed March 2025
Additional biosimilars are in Phase 3 clinical development. EU and UK regulatory plans are as yet unknown.
Planning for implementation
We recommend organisations starts planning for biosimilar omalizumab.
Pharmacy will need to work collaboratively across the integrated system to plan for implementation and identify potential barriers. This will include collaboration with prescribing clinicians, specialist nurses, business managers, finance and contracting teams, pharmaceutical industry and homecare providers.
Implementation checklist
Use our implementation checklist to support planning.
Patient information sheet
SPS has produced a patient information sheet that can be adapted for local use.
Product specific advice
We currently provide product-specific advice for Omlyclo. We will update our article The licence and supporting evidence for omalizumab biosimilar (SPS page) as more biosimilars and formulations become available. Register with SPS and opt in to our weekly email to receive updates on this article and other new biosimilar resources.
SPS resources on biosimilar background
We provide background information on biologic and biosimilar medicines to support those new to the area or for those who would like to refresh their knowledge.
Understanding biological and biosimilar medicines
The licence and supporting evidence for omalizumab biosimilar
SPS resources on pipeline medicines
Be aware of information on pipeline omalizumab biosimilars. Detail is available from:
Update history
- Article updated now that Omlyclo biosimilar is available. Detail provided on other biosimilars in clinical development. Added phase 2 & 3 checklist. Information provided about NHS Framework contract.
- Published