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CHMP backs Garzulys, a new insulin aspart biosimilar referencing NovoRapid

🇪🇺 EMA · Fri 13 Nov 2026

The EMA committee adopted a positive opinion on 12 November 2026 for SciencePharma's insulin aspart biosimilar for diabetes mellitus, with a European Commission decision to follow.

The Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending a marketing authorisation for Garzulys (insulin aspart). The opinion was adopted on 12 November 2026, and EMA published the summary and product page on 13 November.

The applicant is SciencePharma Sp. z o.o. Garzulys will be available as a 100 units/ml solution for injection. It is a biosimilar of NovoRapid (insulin aspart), which was authorised in the EU on 7 September 1999. EMA states that data show comparable quality, safety and efficacy to the reference product.

The recommended indication is the treatment of diabetes mellitus in adults, adolescents and children aged 1 year and above. Insulin aspart is a fast-acting insulin (ATC code A10AB05) with a more rapid onset of action than human soluble insulin. The EMA product number is EMEA/H/C/006677.

The opinion is not yet an authorisation. The European Commission still has to issue its decision. Detailed use recommendations will appear in the summary of product characteristics, which EMA will publish in all official EU languages once the marketing authorisation has been granted.

What it means for your team

  • Regulatory teams should track the European Commission decision, which is the step that turns the CHMP opinion into an EU marketing authorisation.
  • Final SmPC wording, including any conditions, will only be available after authorisation, so labelling and PV planning should wait for those documents.
  • Market-access and portfolio teams covering insulin aspart should note a further biosimilar competitor to NovoRapid is heading for the EU market.

Official source: EMA ↗

Article written by VigiEye from the official source (EMA). AI-assisted; check the source before acting.

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