Donrafylix (insulin aspart)

Where it stands

Donrafylix (insulin aspart), from Kuraci, received a positive CHMP opinion in the EU on 2026-11-12. The records list its status as "Opinion" and give no approval date, so it is not yet authorised in the EU on the evidence provided.

The indication in the records is the treatment of diabetes mellitus from 1 year of age. The therapeutic area is Diabetes Mellitus.

The records give an expected European Commission (EC) decision date of 2027-01-18. This is an estimate, not an official date. It is calculated as the CHMP opinion date plus 67 days, the standard Commission decision period. A positive CHMP opinion is a scientific recommendation, and the legally binding marketing authorisation follows only when the EC adopts its decision.

Regulatory pathway and designations

The product carries a Biosimilar designation. In general, a biosimilar is approved on the basis that it is highly similar to an already authorised reference biological medicine, with no clinically meaningful differences in quality, safety or efficacy. The records do not name the reference product or describe the data package, so nothing can be said here about the comparability evidence.

The CHMP opinion followed by an EC decision indicates the EU centralised procedure. The records show one completed milestone, the CHMP positive opinion (official). The other milestone, the EC decision, is an estimate.

The records list several other entries with the same active substance in the EU and US:

- Garzulys: EU, Opinion; US, Approved. - Dazparda: EU, Authorised. - Kirsty (previously Kixelle): EU, Authorised. - Insulin Aspart Injection: EU, Application withdrawn. - Truvelog Mix 30: EU, Withdrawn. The records do not say which of these are biosimilars, who holds them, or why the withdrawals occurred, so no conclusions should be drawn about them.

Safety and pharmacovigilance

The records contain no safety, risk management or pharmacovigilance information for Donrafylix, so this area cannot be assessed from the data provided.

What to watch

The main near-term event is the EC decision. The records estimate it for 2027-01-18, but this is not an official date, and the actual timing may differ. Confirmation of marketing authorisation would move the status from Opinion to Authorised.

Garzulys (same substance) also holds an EU Opinion status in the records, alongside its US approval. Its EC outcome is worth tracking as a peer in the EU insulin aspart space. The EU market already includes authorised entries (Dazparda and Kirsty, previously Kixelle).

The records give no information on launch timing, pricing, supply or the final wording of the product information. These cannot be assessed until the EC decision and subsequent company communications.