A biosimilar version of liraglutide produced comparable weight loss and blood sugar improvements to the reference drug in Indian patients with type 2 diabetes and obesity over 24 weeks.
p = 0.71No significant difference in weight loss between biosimilar and reference liraglutide at 24 weeks
What the researchers found
In 179 Indian patients with type 2 diabetes and obesity (mean BMI ~29.8 kg/m²), biosimilar liraglutide and reference liraglutide both produced significant weight loss over 24 weeks. The biosimilar group lost 5.5 ± 1.2 kg (7.3% body weight) while the reference group lost 7.1 ± 2.6 kg (8.9% body weight). Crucially, the difference between groups was not statistically significant (p = 0.71), confirming non-inferiority.
Glycemic parameters also improved significantly in both arms: HbA1c (p = 0.89 between groups), fasting plasma glucose (p = 0.43), and postprandial glucose (p = 0.17) were all comparable at week 24, with no meaningful advantage for either formulation.
Why it matters
Liraglutide is an effective but expensive GLP-1 drug for diabetes and weight management. Biosimilars — essentially generic versions of biologic drugs — could dramatically lower costs and improve access, especially in countries like India where affordability is a major barrier to treatment. This study provides clinical evidence that the biosimilar version works just as well.
How the study worked
This was a post-hoc analysis of a Phase III clinical trial. Researchers selected 179 patients with type 2 diabetes and BMI above 25 kg/m² from the larger trial population. One group received biosimilar liraglutide and the other received reference (brand-name) liraglutide at doses up to 1.8 mg daily. The primary endpoint was mean change in body weight from baseline to week 24, with blood sugar measures as secondary endpoints.
What this study cannot tell us
This was a post-hoc analysis, not a prospectively designed weight-loss trial, which weakens the strength of conclusions. The sample size of 179 is modest. The study was conducted only in Indian patients, so results may not generalize to other populations. The 24-week duration is relatively short for assessing weight management outcomes. The numerical weight loss difference (5.5 vs 7.1 kg) was not statistically significant but could be clinically meaningful.
How to read the evidence
This is a post-hoc analysis of a Phase III randomized trial. While the underlying trial was well-designed, post-hoc analyses are considered lower-quality evidence than pre-specified primary analyses because they involve selective examination of subgroups.
When this study was published
Published in 2025, this study reflects the current push toward biosimilar GLP-1 drugs and is highly relevant as patent expirations open the market to lower-cost alternatives.
The bigger picture
As GLP-1 agonists become standard treatments for both diabetes and obesity, their high cost remains a major barrier worldwide. Biosimilar versions could open access to millions of patients in low- and middle-income countries. This study from India adds to the growing evidence that biosimilar peptide drugs can match the originals in efficacy, supporting global efforts to make these treatments affordable.
Questions still open
- Would the biosimilar maintain comparable efficacy over longer treatment periods of 52 weeks or more?
- How much cheaper is the biosimilar version, and does the cost difference meaningfully improve patient access in India?
- Would results be similar at the higher 3.0 mg dose used specifically for weight management rather than the 1.8 mg diabetes dose?
Common questions
What is a biosimilar, and how is it different from a generic drug?
Did the biosimilar cause any different side effects compared to the original?
Read the original research
Effect of liraglutide biosimilar vs. reference liraglutide on weight reduction in T2DM patients with obesity: post hoc analysis of phase III trial.
Cardiovascular diabetology. Endocrinology reports, 11(1), 6
Citation
Ghosh, Sujoy; Sethi, Bipin; Kalra, Sanjay; Baruah, Manash P; Mane, Abhishek; Choudhari, Sanjay; Petare, Anup; Jadhav, Mayur; Patil, Saiprasad; Barkate, Hanmant. (2025). Effect of liraglutide biosimilar vs. reference liraglutide on weight reduction in T2DM patients with obesity: post hoc analysis of phase III trial.. Cardiovascular diabetology. Endocrinology reports, 11(1), 6. https://doi.org/10.1186/s40842-025-00219-7