🇪🇺 US-Lantus® in European Union

EMA authorised US-Lantus® on 26 June 2000

Marketing authorisations

EMA — authorised 26 June 2000

  • Application: EMEA/H/C/000309
  • Marketing authorisation holder: Sanofi-aventis Deutschland GmbH
  • Local brand name: Toujeo (previously Optisulin)
  • Indication: Treatment of diabetes mellitus in adults, adolescents and children from the age of 6 years.
  • Status: approved

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EMA — authorised 9 September 2014

  • Application: EMEA/H/C/002835
  • Marketing authorisation holder: Eli Lilly Nederland B.V.
  • Local brand name: Abasaglar (previously Abasria)
  • Indication: Treatment of diabetes mellitus in adults, adolescents and children aged 2 years and above.
  • Pathway: biosimilar
  • Status: approved

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EMA — authorised 3 January 2017

  • Application: EMEA/H/C/004101
  • Marketing authorisation holder: Merck Sharp & Dohme B.V.
  • Local brand name: Lusduna
  • Indication: Treatment of diabetes mellitus in adults, adolescents and children aged 2 years and above.
  • Pathway: biosimilar
  • Status: withdrawn

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EMA — authorised 11 January 2017

  • Application: EMEA/H/C/004243
  • Marketing authorisation holder: Sanofi Winthrop Industrie
  • Local brand name: Suliqua
  • Indication: Suliqua is indicated for the treatment of adults with insufficiently controlled type 2 diabetes mellitus to improve glycaemic control as an adjunct to diet and exercise in addition to metformin with or without SGLT-2 inhibitors.
  • Status: approved

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EMA — authorised 23 March 2018

  • Application: EMEA/H/C/004280
  • Marketing authorisation holder: Biosimilar Collaborations Ireland Limited
  • Local brand name: Semglee
  • Indication: Treatment of diabetes mellitus in adults, adolescents and children aged 2 years and above.
  • Pathway: biosimilar
  • Status: approved

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EMA — authorised 9 January 2026

  • Application: EMEA/H/C/006136
  • Marketing authorisation holder: Gan & Lee Pharmaceuticals Europe GmbH
  • Local brand name: Ondibta
  • Indication: Treatment of diabetes mellitus in adults, adolescents and children aged 2 years and above.
  • Pathway: biosimilar
  • Status: approved

The European Medicines Agency (EMA) has granted marketing authorisation for Ondibta (US-Lantus biosimilar) on 9 January 2026. This authorisation allows Gan & Lee Pharmaceuticals Europe GmbH to market Ondibta for the treatment of diabetes mellitus in adults, adolescents, and children aged 2 years and above. Ondibta is a biosimilar of the insulin glargine long-acting insulin analogue.

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Frequently asked questions

Is US-Lantus® approved in European Union?

Yes. EMA authorised it on 26 June 2000; EMA authorised it on 9 September 2014; EMA authorised it on 3 January 2017.

Who is the marketing authorisation holder for US-Lantus® in European Union?

Sanofi-aventis Deutschland GmbH holds the EU marketing authorisation.