Garzulys (insulin aspart)

Where it stands

Garzulys (insulin aspart) received a positive CHMP opinion on 12 November 2026. The applicant is Sciencepharma Sp. z o.o, and the product is designated a biosimilar. The indication is the treatment of diabetes mellitus from 1 year of age. The records show no approval date, so the European Commission (EC) has not yet issued its decision.

The records give an estimated EC decision date of 18 January 2027. That is the CHMP opinion date plus 67 days, the standard Commission decision period. It is a calculated estimate, not an official date.

Garzulys also has a US record. The FDA approved it as a biosimilar on 24 July 2026 under BLA761497, as Garzulys (insulin aspart-fsan), in pen and vial presentations. The US sponsor is listed as Emerge Bioscience Pte. Ltd., a different company from the EU applicant. The records do not explain how the two companies are related.

Regulatory pathway and designations

The EU record carries a Biosimilar designation. In general, a CHMP opinion is the scientific recommendation. It becomes a marketing authorisation valid across the EU only once the EC adopts its decision. The 67-day window is the usual period between those two steps.

In the US, the FDA approved the product under a Biologics License Application (BLA761497) with a biosimilar designation. The records do not state the reference product or any interchangeability status. They also do not give the EU presentations or the full approved wording beyond the indication above.

Other EU records exist for the same substance. Dazparda and Kirsty (previously Kixelle) are authorised, and Donrafylix is at the opinion stage. An Insulin Aspart Injection application was withdrawn, and Truvelog Mix 30 is listed as withdrawn. The records do not give the reasons for either withdrawal or say which of these products are biosimilars.

Safety and pharmacovigilance

The records contain no safety data, risk management plan details or pharmacovigilance commitments for Garzulys, so no assessment can be made here.

What to watch

The main near-term event is the EC decision. The estimated date is 18 January 2027, but the actual date may differ. The published decision should also confirm the final authorised indication and the marketing authorisation holder.

Donrafylix is also at the opinion stage for the same substance, so its progress is worth following. Dazparda and Kirsty are already authorised in the EU, which is the context for the Garzulys decision.

The records do not explain how Sciencepharma Sp. z o.o and Emerge Bioscience Pte. Ltd. relate to each other. They also do not say whether the EU and US products share the same presentations. Anyone relying on those points should check them against primary sources.