Regulatory Decision Summary for Xolair

The purpose of this submission was to seek market authorization, pursuant to section C.08.004 of the Food and Drugs Regulations, for new 300 mg/2 mL product presentations consisting in a pre-filled syringe (PFS) with a needle safety device (NSD) and a pre-filled syringe in an autoinjector (AI) of omalizumab. Omalizumab is currently authorized as 75mg/0.5 mL and 150 mg/1 mL in a pre-filled syringe with needle safety device presentations.

In this Supplement to a New Drug Submission (SNDS), no changes to the currently authorized indication or posology were sought, only the authorization of the new 300 mg/2 mL presentations of omalizumab.

The authorization was based on Study CIGE025K12101 which compared the relative bioavailability of the new drug product presentations of omalizumab (300 mg/2 mL in a PFS-NSD and PFS-AI) with that of the currently authorized presentation (150 mg/1 mL in a PFS-NSD) in healthy subjects. The omalizumab 150 mg/1 mL and 300 mg/2 mL presentations were shown to meet the pre-specified criteria for bioequivalence when administered subcutaneously as a single dose of 300 mg. There was no meaningful differences in exposure between the authorized omalizumab 150 mg/1 mL and the new 300 mg/2 mL presentations. The new 300 mg/2 mL presentations require only half the number of injections of the 150 mg/1 mL presentation to achieve the same prescribed dose of 300 mg. Based on the comparative bioavailability data, no differences in terms of efficacy is expected based on this change.

The safety profile of the omalizumab 300 mg/2 mL presentations were consistent with the safety profile of the 150 mg/1 mL presentation, when administered as a single dose in healthy subjects. No new or unexpected safety findings were identified.

The benefit/risk profile of omalizumab remains favourable for all the indications for which this product is authorized.

An updated Risk Management Plan (RMP) for Xolair was reviewed by Health Canada and considered acceptable.

The chemistry and manufacturing information submitted for Xolair has demonstrated that the drug substance and drug product can be consistently manufactured to meet the approved specifications.

Following review and requested revisions, the final labelling and Product Monograph were considered to be acceptable.

For further details about Xolair, please refer to the Product Monograph, approved by Health Canada and available through the Drug Product Database.