Post‐marketing safety of Lantus and its interchangeable biosimilar Semglee in the United States: A disproportionality analysis using the FDA Adverse Event Reporting System ( FAERS ) database
Authors' conclusion
Findings identified significant post-marketing safety signals of Lantus and Semglee. Longitudinal studies are warranted to verify these signals.
Study context
- Population
- Adverse Event (AE) reports for Lantus and Semglee in the FDA Adverse Event Reporting System, US
- Comparison
- Lantus (insulin glargine) and its interchangeable biosimilar Semglee (insulin glargine-yfgn): reporting safety signals
- Outcome
- Safety signals for serious AE, death, hospitalization, top 6 high-level group terms (HLGTs) and specific AEs on products' FDA prescription labels
Methodological detailsFDA Adverse Event Reporting System (FAERS), reporting odds ratio (ROR), empirical Bayesian geometric mean (EBGM), Medical Dictionary for Regulatory Activities (MedDRA) high-level group terms
- FDA Adverse Event Reporting System (FAERS)
- Reporting odds ratio (ROR)
- Empirical Bayesian geometric mean (EBGM)
- MedDRA high-level group terms
Main finding
As reported in the abstract
Safety signals (disproportionality)
| Group | Device issues ROR (95% CI) | Device issues EBGM (90% CI) | Medication errors and other product use errors and issues ROR (95% CI) | Medication errors and other product use errors and issues EBGM (90% CI) | Metabolic, nutritional and blood gas investigations ROR (95% CI) | Metabolic, nutritional and blood gas investigations EBGM (90% CI) | Hyperglycaemia ROR (95% CI) | Hyperglycaemia EBGM (90% CI) | Hypoglycaemia ROR (95% CI) | Hypoglycaemia EBGM (90% CI) | Product quality, supply, distribution, manufacturing and quality system issues ROR (95% CI) | Product quality, supply, distribution, manufacturing and quality system issues EBGM (90% CI) | Physical examination and organ system status topics ROR (95% CI) | Physical examination and organ system status topics EBGM (90% CI) | Weight gain ROR (95% CI) | Weight gain EBGM (90% CI) | Weight loss ROR (95% CI) | Weight loss EBGM (90% CI) | Lipodystrophy ROR (95% CI) | Lipodystrophy EBGM (90% CI) |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Lantus | 1.3 (1.2-1.4) | 1.3 (1.2-1.3) | 2.8 (2.7-2.9) | 2.1 (2.0-2.1) | 11.7 (11.2-12.2) | 9.6 (9.3-9.9) | 2.7 (2.1-3.5) | 2.3 (1.9-2.8) | 4.6 (3.6-5.8) | 3.7 (3.0-4.5) | ||||||||||
| Semglee | 118.7 (103.9-135.7) | 22.8 (21.7-23.9) | 3.4 (3.0-3.8) | 2.3 (2.1-2.4) | 3.0 (2.3-3.9) | 2.5 (2.0-3.1) | 5.4 (4.6-6.3) | 4.4 (3.9-5.0) | 2.6 (2.0-3.2) | 2.2 (1.9-2.7) | 3.6 (2.6-4.8) | 2.7 (2.1-3.5) | 2.0 (1.4-2.9) | 1.7 (1.2-2.2) | 146.0 (96.1-221.8) | 116.0 (81.7-160.8) |
Device issues ROR (95% CI)
Lantus1.3 (1.2-1.4)
Semglee118.7 (103.9-135.7)
Device issues EBGM (90% CI)
Lantus1.3 (1.2-1.3)
Semglee22.8 (21.7-23.9)
Medication errors and other product use errors and issues ROR (95% CI)
Lantus2.8 (2.7-2.9)
Semglee3.4 (3.0-3.8)
Medication errors and other product use errors and issues EBGM (90% CI)
Lantus2.1 (2.0-2.1)
Semglee2.3 (2.1-2.4)
Metabolic, nutritional and blood gas investigations ROR (95% CI)
Lantus11.7 (11.2-12.2)
Semglee3.0 (2.3-3.9)
Metabolic, nutritional and blood gas investigations EBGM (90% CI)
Lantus9.6 (9.3-9.9)
Semglee2.5 (2.0-3.1)
Hyperglycaemia ROR (95% CI)
Lantus2.7 (2.1-3.5)
Semglee— not stated in the abstract
Hyperglycaemia EBGM (90% CI)
Lantus2.3 (1.9-2.8)
Semglee— not stated in the abstract
Hypoglycaemia ROR (95% CI)
Lantus4.6 (3.6-5.8)
Semglee— not stated in the abstract
Hypoglycaemia EBGM (90% CI)
Lantus3.7 (3.0-4.5)
Semglee— not stated in the abstract
Product quality, supply, distribution, manufacturing and quality system issues ROR (95% CI)
Lantus— not stated in the abstract
Semglee5.4 (4.6-6.3)
Product quality, supply, distribution, manufacturing and quality system issues EBGM (90% CI)
Lantus— not stated in the abstract
Semglee4.4 (3.9-5.0)
Physical examination and organ system status topics ROR (95% CI)
Lantus— not stated in the abstract
Semglee2.6 (2.0-3.2)
Physical examination and organ system status topics EBGM (90% CI)
Lantus— not stated in the abstract
Semglee2.2 (1.9-2.7)
Weight gain ROR (95% CI)
Lantus— not stated in the abstract
Semglee3.6 (2.6-4.8)
Weight gain EBGM (90% CI)
Lantus— not stated in the abstract
Semglee2.7 (2.1-3.5)
Weight loss ROR (95% CI)
Lantus— not stated in the abstract
Semglee2.0 (1.4-2.9)
Weight loss EBGM (90% CI)
Lantus— not stated in the abstract
Semglee1.7 (1.2-2.2)
Lipodystrophy ROR (95% CI)
Lantus— not stated in the abstract
Semglee146.0 (96.1-221.8)
Lipodystrophy EBGM (90% CI)
Lantus— not stated in the abstract
Semglee116.0 (81.7-160.8)
Original publication
Post‐marketing safety of Lantus and its interchangeable biosimilar Semglee in the United States: A disproportionality analysis using the FDA Adverse Event Reporting System ( FAERS ) database. Diabetes Obes Metab. Published 29 May 2025. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →