Ondibta

Opinion

EMA has issued an opinion on this medicine

insulin glargine

Overview

On 13 November 2025, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Ondibta, intended for the treatment of diabetes mellitus.

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

Ondibta will be available as a 100 units/ml solution for injection. The active substance of Ondibta is insulin glargine, a long-acting insulin analogue (ATC code: A10AE04). Insulin glargine binds specifically to the human insulin receptor and results in the same pharmacological effects as human insulin.

Ondibta is a biosimilar medicinal product. It is highly similar to the reference product Lantus (insulin glargine), which was authorised in the EU on 9 June 2000. Data show that Ondibta has comparable quality, safety and efficacy to Lantus (insulin glargine).

The full indication is:

Treatment of diabetes mellitus in adults, adolescents and children aged 2 years 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 Ondibta

Adopted Reference Number: EMA/337755/2025

Product details

• Name of medicine:
  Ondibta
• Active substance:
  insulin glargine
• International non-proprietary name (INN) or common name:
  insulin glargine
• Therapeutic area (MeSH):
  Diabetes Mellitus
• Anatomical therapeutic chemical (ATC) code:
  A10AE04
• EMA product number:
  EMEA/H/C/006136
• 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:
  13/11/2025
• Opinion status:
  Positive