Dazparda

Opinion

EMA has issued an opinion on this medicine

insulin aspart

Overview

On 26 February 2026, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Dazparda, intended for the treatment of diabetes mellitus.

The applicant for this medicinal product is Gan & Lee Pharmaceuticals Europe GmbH.

Dazparda will be available as a 100 unit/ml solution for injection in a pre-filled pen. The active substance of Dazparda is insulin aspart, a fast-acting insulin analogue (ATC code: A10AB05), which has a more rapid onset of action than human soluble insulin. The blood glucose lowering effect of insulin aspart is due to the facilitated uptake of glucose following binding of insulin to receptors on muscle and fat cells and to the simultaneous inhibition of glucose output from the liver.

Dazparda is a biosimilar medicinal product. It is highly similar to the reference product NovoRapid (insulin aspart), which was authorised in the EU on 7 September 1999. Data show that Dazparda has comparable quality, safety and efficacy to NovoRapid.

The full indication is:

Dazparda is indicated for treatment of diabetes mellitus in adults, adolescents and children aged 1 year and above.

Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published on the EMA website in all official European Union languages after the marketing authorisation has been granted by the European Commission.

CHMP summary of positive opinion for Dazparda

Adopted Reference Number: EMA/CHMP/37389/2026

Product details

• Name of medicine:
  Dazparda
• Active substance:
  insulin aspart
• International non-proprietary name (INN) or common name:
  insulin aspart
• Therapeutic area (MeSH):
  Diabetes Mellitus
• Anatomical therapeutic chemical (ATC) code:
  A10AB05
• EMA product number:
  EMEA/H/C/006187
• Biosimilar:

  This is a biosimilar medicine, which is a biological medicine highly similar to another already approved biological medicine called the ‘reference medicine’. For more information, see Biosimilar medicines.

• Marketing authorisation applicant:
  Gan & Lee Pharmaceuticals Europe GmbH
• Opinion adopted:
  26/02/2026
• Opinion status:
  Positive