The licence and supporting evidence for omalizumab biosimilar

Scope

We provide information relating to indications, formulations, evidence and differences between biosimilars at the point of licensing onwards.

There is no certainty that listed products will be included on the NHS framework. We will update this article with information as it becomes available or as additional biosimilars progress through the regulatory process.

Licensed indications

Omalizumab biosimilar (Omlyclo; Celltrion) is licensed for the same indications as the reference product Xolair (Novartis). Refer to the individual summary of medicinal product characteristics (SmPC) for further information.

Note: the 75mg strength preparation (Xolair; Novartis and Omlyclo; Celltrion) is not licensed for chronic spontaneous urticaria. 

Licensed preparations

Omlyclo (Celltrion), is licensed as pre-filled syringes and pens. Omalizumab biosimilar will be available ahead of NHS framework awards. The pre-filled syringes are likely to be available from the end of September and the pre-filled pens shortly after. It is anticipated that a 300mg strength product will be available in 2026.

Evidence supporting safety and efficacy

The clinical efficacy, safety profile and immunogenicity of omalizumab biosimilar (Omlyclo) and the reference product (Xolair) are similar.

Efficacy data

In a randomised, double-blind, active controlled parallel group study, 409 patients aged between 12 and 75 years with chronic spontaneous urticaria (CSU) not responding to antihistamine treatment received Omlyclo (biosimilar omalizumab, CT-P39) or the reference product (Xolair). The study demonstrated similarity in clinical efficacy after 12 weeks of treatment. The weekly itch severity score (ISS7) was reduced by an average of 9.21 points in people who received Omlyclo compared with an average of 9.98 points in those who received Xolair [95% CI, -0.37, 1.90] which was within the predefined equivalence margin of [-2.0, 2.0].

For further details see the published abstract or the European Public Assessment Report.

Extrapolation of data to other indications

Omlyclo is considered highly similar to the reference product (Xolair) based on results of the clinical trial in patients with CSU. Its licence is extrapolated to the additional indications already approved (licensed) for the reference product (Xolair). Thus, avoiding unnecessary repetition of clinical trials.

The CSU population was chosen for the biosimilar efficacy study in preference to that with allergic asthma. Patients with CSU were considered a more homogenous population and therefore more sensitive to any potential differences between products.

See understanding biological and biosimilar medicines for further information regarding the regulatory process for biosimilar medicines.

Pharmacokinetic trial data

In a published randomised, double-blind, two-part, single-dose, pharmacokinetic study 146 healthy adults received 150mg Omlyclo or Xolair. The study demonstrated primary outcomes of pharmacokinetic parameters within pre-specified equivalence margins. Safety and immunogenicity were comparable between products.

Differences between brands

Comparison of pharmaceutical aspects between omalizumab biosimilar (Omlyclo) and the reference product (Xolair).

Administration

The first three doses of omalizumab must be administered by or under the supervision of a healthcare professional. For those with no known history of anaphylaxis, patients or caregivers can administer omalizumab (Xolair, or Omlyclo) from the fourth dose onwards. Appropriate training should be provided.

Switching between brands

Information relating to administration is molecule-specific rather than brand-specific. Providing appropriate training on the new device has been provided:

• those stable self-administering originator can switch to self-administration of the biosimilar (Omlyclo)
• those stable receiving carer-administered originator can switch to carer-administration of the biosimilar (Omlyclo)

Packaging and associated risks

To minimise errors, consider processes to avoid inadvertent switching between omalizumab originator and biosimilar.

Omlyclo

Be aware of differences in packaging colour that could cause confusion. Xolair uses blue to identify the 75mg doses, whereas Omlyclo uses blue to identify the 150mg dose. Ensure there are processes in place to avoid mis-selection, especially if there is a period when both brands are available.

Excipients

There are no differences between the excipients listed in the reference product (Xolair) and the biosimilar (Omlyclo).

The Omlyclo SmPC expresses the L-isomer forms of several excipients, for example L-histidine. L-histidine is a synonym for histidine; the terms can be used interchangeably.

Presence of latex

Differences do exist between omalizumab products

Xolair pre-filled syringes

The removable needle cap may contain dry rubber (latex) and should not be handled by anyone who is sensitive to latex. Use of the injection in latex-sensitive individuals has not been studied, therefore risk of a hypersensitivity reaction cannot be ruled out.

Xolair pre-filled pens

The product information for Xolair pre-filled pens makes no reference to presence of latex. Novartis have confirmed that none of the components contain natural rubber latex.

Omlyclo (all presentations)

The needle cap of the pre-filled syringes and pens is made of synthetic materials (elastomer and polypropylene).

Storage and stability

Comparisons of storage and in use stability between omalizumab biosimilars and the reference product (Xolair):

Omlyclo

Store in a refrigerator (2 °C to 8 °C). 

The product may be kept for a total of 7 days at room temperature (25 °C) 

Xolair

Store in a refrigerator (2 °C to 8 °C). 

The product may be kept for a total of 48 hours at room temperature (25 °C) 

Further resources

SPS have further resources on biosimilars and biosimilar omalizumab. 

Update history