| アブストラクト | AIMS: On 28 July 2021, Semglee (insulin glargine-yfgn) was approved by the U.S. Food and Drug Administration as the first interchangeable biosimilar to the reference product Lantus (insulin glargine) for treating diabetes mellitus. This study used the FDA Adverse Event Reporting System to identify reporting safety signals of Lantus and Semglee. MATERIALS AND METHODS: Adverse event (AE) reports were organized into high-level group terms (HLGTs) using the Medical Dictionary for Regulatory Activities (MedDRA). Disproportionality analysis, including reporting odds ratio (ROR) and empirical Bayesian geometric mean (EBGM), was performed to detect safety signals for serious AE, death, hospitalization, top 6 HLGTs, and specific AEs on products' FDA prescription labels. RESULTS: Both products showed no significant safety signal of serious AE, death, or hospitalization. Lantus exhibited significant safety signals for device issues (ROR = 1.3, 95% confidence interval [CI] = 1.2-1.4; EBGM = 1.3, 90% CI = 1.2-1.3), medication errors and other product use errors and issues (ROR = 2.8, 95% CI = 2.7-2.9; EBGM = 2.1, 90% CI = 2.0-2.1), metabolic, nutritional, and blood gas investigations (ROR = 11.7, 95% CI = 11.2-12.2; EBGM = 9.6, 90% CI = 9.3-9.9), hyperglycaemia (ROR = 2.7, 95% CI = 2.1-3.5; EBGM = 2.3, 90% CI = 1.9-2.8) and hypoglycaemia (ROR = 4.6, 95% CI = 3.6-5.8; EBGM = 3.7, 90% CI = 3.0-4.5). Semglee had significant safety signals for device issues (ROR = 118.7, 95% CI = 103.9-135.7; EBGM = 22.8, 90% CI = 21.7-23.9), medication errors and other product use errors and issues (ROR = 3.4, 95% CI = 3.0-3.8; EBGM = 2.3, 90% CI = 2.1-2.4), metabolic, nutritional, and blood gas investigations (ROR = 3.0, 95% CI = 2.3-3.9; EBGM = 2.5, 90% CI = 2.0-3.1), product quality, supply, distribution, manufacturing, and quality system issues (ROR = 5.4, 95% CI = 4.6-6.3; EBGM = 4.4, 90% CI = 3.9-5.0), physical examination and organ system status topics (ROR = 2.6, 95% CI = 2.0-3.2; EBGM = 2.2, 90% CI = 1.9-2.7), weight gain (ROR = 3.6, 95% CI = 2.6-4.8; EBGM = 2.7, 90% CI = 2.1-3.5), weight loss (ROR = 2.0, 95% CI = 1.4-2.9; EBGM = 1.7, 90% CI = 1.2-2.2), and lipodystrophy (ROR = 146.0, 95% CI = 96.1-221.8; EBGM = 116.0, 90% CI = 81.7-160.8). CONCLUSIONS: Findings identified significant post-marketing safety signals of Lantus and Semglee. Longitudinal studies are warranted to verify these signals. |
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