Ensuring familiarity with the area
Pharmacy teams and clinicians planning to use an 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 it is not routinely commissioned because Novartis did not submit evidence 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 in 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 Framework awards
The Medicines Procurement and Supply Chain (MPSC) web catalogue provides information about products available on NHS England procurement frameworks. Further information on procurement arrangements is available in the SPS article series, Procurement of medicines and services for NHS secondary care (SPS page).
The framework for this biosimilar was awarded nationally. The two biosimilars discussed in this article are available through NHS procurement framework arrangements.
Adcomfo (Advanz)
Product information available via MHRA website
Omlyclo (Celltrion)
Product information available via EMC website
In development
Other omalizumab biosimilars are in development. Information on biosimilars in development is available in our Annual medicines planning publication, Prescribing Outlook (SPS page)
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 involves working with clinicians, nurses, managers, finance, contracting teams, industry partners 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 provide product-specific advice in our article The licence and supporting evidence for omalizumab biosimilar (SPS page). This article will be updated 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 for those new to the area or needing a knowledge refresh.
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
- Streamlined for consistency with other biosimilar pages.
- Removed reference to available formulations. For information see licence and evidence page.
- Article updated now that Adcomfo biosimilar is licensed.
- 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