Ondibta (insulin glargine)
BiosimilarAdditional monitoring
- Region
- 🇪🇺 EU
- Active substance
- insulin glargine
- Company
- Sandoz GmbH
- Status
- Authorised
- Therapeutic area
- Diabetes Mellitus
- CHMP opinion
- Thu 13 Nov 2025
- EU approval
- Fri 09 Jan 2026
- Designations
- Biosimilar, Additional monitoring
- Application
- EMEA/H/C/006136
- ATC
- A10AE04
- Official record
- www.ema.europa.eu
Indication
Treatment of diabetes mellitus in adults, adolescents and children aged 2 years and above.
Regulatory milestones
Fri 09 Jan 2026🇪🇺 EU approval (EC decision)
Ondibta (insulin glargine) approved in the EU
Marketing authorisation to Sandoz GmbH; Biosimilar, Additional monitoring · source
Thu 13 Nov 2025🇪🇺 CHMP positive opinion
Ondibta (insulin glargine): CHMP positive opinion
Sandoz GmbH; Biosimilar, Additional monitoring · source
Same substance in other markets
- 🇪🇺 Semglee Authorised · Biosimilar Collaborations Ireland Limited
- 🇺🇸 Langlara Approved · Sunshine Lake Pharma Co Ltd
- 🇪🇺 Suliqua Authorised · Sanofi Winthrop Industrie
- 🇪🇺 Abasaglar (previously Abasria) Authorised · Eli Lilly Nederland B.V.
- 🇪🇺 Toujeo (previously Optisulin) Authorised · Sanofi-aventis Deutschland GmbH
- 🇪🇺 Lantus Authorised · sanofi-aventis Deutschland GmbH
- 🇪🇺 Lusduna Withdrawn · Merck Sharp & Dohme B.V.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.