Therapeutic equivalence and switching between biosimilar and reference insulins: A systematic review and meta‐analysis of randomised controlled trials
Authors' conclusion
No statistically significant differences were found in the efficacy, primary safety and immunogenicity between biosimilar insulins and reference insulins. These findings support biosimilar insulins' adoption to enhance treatment access and cost-effectiveness.
Study context
- Population
- Patients with diabetes in RCTs: equivalence trials (biosimilar vs reference) and switching trials (reference insulin run-in, then randomised to switch to biosimilar or continue reference)
- Participants
- 10,617 patients25 RCTs
- Comparison
- Biosimilar insulins vs reference insulins
- Outcome
- Change in HbA1c
Methodological detailstherapeutic equivalence trials, switching trials, MEDLINE, Embase and Cochrane Library searched from inception to March 2025
- Therapeutic equivalence trials
- Switching trials
- MEDLINE, Embase and Cochrane Library searched from inception to March 2025
Pooled result
As reported in the abstract
Equivalence analysis (16 RCTs, n = 6548): MD in HbA1c change, 95% CI −0.04, 0.06
0.01%
Switching analysis (9 RCTs, n = 4069): MD in HbA1c change, 95% CI −0.06, 0.05
−0.01%
Further pooled results
Achieving HbA1c <7.0%
- Equivalence analysis: OR, 95% CI 0.88, 1.12
- 0.99
- Switching analysis: OR, 95% CI 0.86, 1.27
- 1.05
- No significant difference
Change in fasting blood glucose (FBG)
mmol/L
- Equivalence analysis: MD, 95% CI −0.06, 0.22
- 0.08
- Switching analysis: MD, 95% CI −0.18, 0.40
- 0.11
- No significant difference
Original publication
Therapeutic equivalence and switching between biosimilar and reference insulins: A systematic review and meta‐analysis of randomised controlled trials. Diabetes Obes Metab. Published 28 November 2025. doi:10.
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