Bysumlog (insulin lispro)
BiosimilarAdditional monitoring
- Region
- 🇪🇺 EU
- Active substance
- insulin lispro
- Company
- Sandoz GmbH
- Status
- Authorised
- Therapeutic area
- Diabetes Mellitus
- CHMP opinion
- Thu 26 Feb 2026
- EU approval
- Wed 06 May 2026
- Designations
- Biosimilar, Additional monitoring
- Application
- EMEA/H/C/006158
- ATC
- A10AB04
- Official record
- www.ema.europa.eu
Indication
For the treatment of adults and children with diabetes mellitus who require insulin for the maintenance of normal glucose homeostasis. Bysumlog is also indicated for the initial stabilisation of diabetes mellitus.
Regulatory milestones
Wed 06 May 2026🇪🇺 EU approval (EC decision)
Bysumlog (insulin lispro) approved in the EU
Marketing authorisation to Sandoz GmbH; Biosimilar, Additional monitoring · source
Thu 26 Feb 2026🇪🇺 CHMP positive opinion
Bysumlog (insulin lispro): CHMP positive opinion
Sandoz GmbH; Biosimilar, Additional monitoring · source
Same substance in other markets
- 🇪🇺 Lyumjev (previously Liumjev) Authorised · Eli Lilly Nederland B.V.
- 🇪🇺 Humalog Authorised · Eli Lilly Nederland B.V.
- 🇪🇺 Insulin lispro Sanofi Authorised · Sanofi Winthrop Industrie
- 🇪🇺 Liprolog Authorised · Eli Lilly Nederland B.V.
- 🇪🇺 Liprolog Withdrawn · Eli Lilly and Company Limited
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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.