Preparing to use omalizumab biosimilar

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:

• Pre-filled syringes; 75mg, 150mg and 300mg
• Pre-filled pens; 75mg, 150mg and 300mg

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.

Licensed products

One omalizumab biosimilar (Omlyclo; Celltrion) is currently licensed by the MHRA for the same indications as the reference product (Xolair). Licensed products include:

• Pre-filled syringes; 75mg and 150mg 
• Pre-filled pens; 75mg and 150mg

The NHS framework is not yet awarded. It is anticipated that Celltrion will launch ahead of framework with pre-filled syringes available by the end of September and pre-filled pens shortly after. It is anticipated that a 300mg strength product will be available 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

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 phase one implementation checklist to support planning. Phase two checklist coming soon.

• Omalizumab Implementation Checklist Phase 1 FINAL v1.0Opens in a new window · Word · 47 KB

Patient information sheet

SPS has produced a patient information sheet that can be adapted for local use.

• Omalizumab Patient Information Sheet FINAL v.1.0Opens in a new window · Word · 41 KB

Product specific advice

We will endeavour to provide additional information relating to key differences between biosimilar products as soon as possible. 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.

SPS resources on pipeline medicines

Be aware of information on pipeline omalizumab biosimilars. Detail is available from:

• Our annual planning advice for new medicines