Semglee (insulin glargine)
Biosimilar
- Region
- 🇪🇺 EU
- Active substance
- insulin glargine
- Company
- Biosimilar Collaborations Ireland Limited
- Status
- Authorised
- Therapeutic area
- Diabetes Mellitus
- CHMP opinion
- Thu 25 Jan 2018
- EU approval
- Fri 23 Mar 2018
- Designations
- Biosimilar
- Application
- EMEA/H/C/004280
- 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
No milestones recorded in the last year.
Same substance in other markets
- 🇺🇸 Langlara Approved · Sunshine Lake Pharma Co Ltd
- 🇪🇺 Suliqua Authorised · Sanofi Winthrop Industrie
- 🇪🇺 Ondibta Authorised · Sandoz GmbH
- 🇪🇺 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- 🇪🇺 Lusduna Withdrawn · Merck Sharp & Dohme B.V.
Follow Semglee
Get VigiEye Daily: approvals, opinions, safety actions and PDUFA dates every morning.
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.