Adcomfo (omalizumab)

Where it stands

Adcomfo (omalizumab), from Advanz Pharma Limited, received a positive CHMP opinion on 17 September 2026. The records show its status as "Opinion" and give no approval date, so it is not yet authorised in the EU. The CHMP opinion is the only official milestone recorded.

The proposed indication is the treatment of asthma, chronic rhinosinusitis with nasal polyps (CRSwNP) and chronic spontaneous urticaria (CSU). The records do not give the detailed wording, such as age groups, severity criteria or add-on therapy conditions. Those details will appear in the final product information.

The records give an expected European Commission (EC) decision date of 23 November 2026. This is an estimate, not an official date. It is calculated as the CHMP opinion date plus 67 days, the standard Commission decision period. The actual date may differ.

Regulatory pathway and designations

The only designation recorded is Biosimilar. In the EU, a CHMP opinion is a scientific recommendation. Marketing authorisation is granted by the European Commission, normally after the opinion. For a biosimilar, the opinion indicates that the CHMP considers the product sufficiently similar to an authorised biologic in quality, safety and efficacy.

The records list two other EU-authorised products with the same substance: Xolair and Omlyclo. They do not say which product Adcomfo references, what comparability data supported the opinion, or how the indications compare across these products. No conclusions on those points can be drawn from the records.

The records also contain no information on orphan status, conditional approval, accelerated assessment or other special pathways. They give no detail on the procedure, such as timelines or clock stops.

Safety and pharmacovigilance

The records contain no safety data for Adcomfo. They do not cover the risk management plan, additional monitoring, warnings, contraindications or post-authorisation commitments.

As general procedure, EU medicines, including biosimilars, are authorised with a risk management plan and are covered by routine pharmacovigilance. The final product information and any conditions will be published with the Commission decision and the EPAR. These documents are the appropriate sources for Adcomfo's safety information once available.

What to watch

The main event is the EC decision, estimated for 23 November 2026. It is not an official date. A final decision would convert the positive opinion into a marketing authorisation valid in the EU.

After the decision, the final summary of product characteristics, the indications as authorised and any conditions should be checked against the records' description of asthma, CRSwNP and CSU. The records do not cover launch timing, pricing, reimbursement or market access, so none of these can be assessed here.