Semglee

Authorised

Human

Biosimilar

Details

EMA number	EMEA/H/C/004280
ATC code	A10AE04
Authorisation	23 March 2018
Revision	12

EMA page

Therapeutic indication

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

MeSH: Diabetes Mellitus

Group: Drugs used in diabetes

Active substances

insulin glargine

Marketing Authorisation Holder

MAH

🇺🇸 Also approved in the US (FDA)

TOUJEO — SANOFI US SERVICES, approved 2024-08-29 (BLA206538).

Most reported adverse events (US / FAERS)

159,088 reports across the top reactions. These are spontaneously reported events from the FDA Adverse Event Reporting System — they reflect reporting volume, not incidence or frequency, and a report does not mean the drug caused the event.

blood glucose increased

38,999

off label use

12,800

drug ineffective

10,527

blood glucose decreased

10,483

Timeline

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Semglee authorised

23 Mar 2018

authorisedregulatory

🇺🇸 Also approved in the US (FDA)

TOUJEO — SANOFI US SERVICES, approved 2024-08-29 (BLA206538).

Most reported adverse events (US / FAERS)

159,088 reports across the top reactions. These are spontaneously reported events from the FDA Adverse Event Reporting System — they reflect reporting volume, not incidence or frequency, and a report does not mean the drug caused the event.

blood glucose increased

38,999

off label use

12,800

drug ineffective

10,527

blood glucose decreased

10,483

inappropriate schedule of product administration

10,129

nausea

9,897

product storage error

9,255

visual impairment

8,804

hypoglycaemia

7,925

diarrhoea

7,139

fatigue

6,936

incorrect dose administered

6,737

malaise

6,658

weight decreased

6,411

injection site pain

6,388