Dulaglutide Biosimilar Achieves Equivalent Efficacy in HbA1c Reduction in Patients With T2DM

LY05008 (BA5101; Boan Biotech), a biosimilar to the glucagon-like peptide-1 (GLP-1) receptor agonist dulaglutide (Trulicity; Eli Lilly & Co), demonstrated comparable safety, pharmacokinetics, and immunogenicity profiles to its reference product. The findings were published in the Journal of Diabetes and showed that the biosimilar had equivalent efficacy in reducing hemoglobin A_1c (HbA_1c) in Chinese adults with type 2 diabetes mellitus (T2DM).¹

Image credit: Edugrafo | stock.adobe.com

Dulaglutide is a once-weekly injectable GLP-1 receptor agonist that was approved by the FDA in September 2014 for the treatment of adults with T2DM. It is not recommended as a first-line therapy for those whose diabetes is inadequately controlled with diet and exercise. Additionally, it is not recommended for those with type 1 diabetes, diabetic ketoacidosis, or preexisting severe gastrointestinal disease. It is administered as a subcutaneous injection once per week in the thigh, abdomen, or upper arm. The initial dose is 0.75 mg; however, this can be increased to 1.5 mg for additional glycemic control if necessary.^2,3 In addition to improving glycemic control, dulaglutide has also been shown to be effective at reducing the risk of cardiovascular adverse events (AEs).¹

The development of LY05008 occurred in accordance with related guidelines for biosimilars by Boan Biotech, wrote the manufacturers. Preclinical head-to-head comparative studies demonstrated that LY05008 is highly similar to dulaglutide in terms of physicochemical and functional properties. Additionally, phase 1 trial results showed a high degree of similarity in pharmacokinetic profiles.⁴ LY05008 was granted marketing in China under the name Boyouping.⁵

Results from a previous study featuring healthy male Chinese patients demonstrated the pharmacokinetic similarity of LY05008 and its reference product, with comparable safety and immunogenicity profiles. Following these findings, a well-controlled phase 3 study with an adequate sample size was conducted for safety and efficacy evaluation.¹

This study is a multicenter, randomized, open-label, active comparator phase 3 study that enrolled 440 Chinese adults with T2DM. These patients were randomly assigned to receive a 1.5-mg subcutaneous injection of either LY05008 (n = 222) or dulaglutide (n = 218) once per week for a 24-week duration. The trial’s primary end point was the mean change in HbA_1c from baseline to week 24, and secondary end points included the following: mean change in HbA_1c to week 12; the proportion of patients who achieved an HbA_1c of 6.5% or less at weeks 12 and 24; and the mean change in body weight, fasting plasma glucose (FPG) level, and 2-hour postprandial plasma glucose (PPG) from baseline to weeks 12 and 24.¹

The findings showed that the mean changes in HbA_1c from baseline to week 24 were approximately –1.44% and –1.41% in the LY05008 and dulaglutide groups, respectively (95% CI –0.08, 0.19; P > .05). Additionally, mean changes from baseline to week 12 in these respective groups were –1.47% and –1.39% (P > .05). Specifically, at week 12, about 40.1% and 42.2% of those who received the biosimilar and the reference product, respectively, had a decrease in the HbA_1c level to 6.5% or less, whereas 60.4% and 60.6% of patients had a decrease less than 7%. At week 24, these reduction were present in 41.0% and 43.6% of patients (≤ 6.5%) and 55.9% and 66.5% of patients (< 7%) in the LY05008 and dulaglutide groups.¹

Regarding secondary end points, mean changes in body weight from baseline to weeks 12 and 24 were about –2.01 and –1.71 kg (P > .05) in the LY05008 group and –2.68 and –2.42 kg (P > .05) in the dulaglutide group, respectively. For FPG levels, these changes were about −2.578 and −2.222 mmol/L (LY05008) and −2.681 and −2.690 mmol/L (dulaglutide; P > .05) from baseline to weeks 12 and 24. In the LY05008 group and the dulaglutide group, the mean changes in 2-hour PPG levels from baseline to weeks 12 and 24 were −4.364 and −4.800 mmol/L (P > 0.05) and −3.502 and −4.217 mmol/L (P > 0.05), respectively.¹

The most common treatment-emergent AEs in both treatment groups were decreased appetite, diarrhea, upper respiratory tract infection, hyperuricemia, nausea, urinary tract infection, and vomiting; however, most of these were mild to moderate in severity, and there were no significant differences observed between the 2 groups. Hypoglycemic events were observed in both groups (LY05005: 0.9%; dulaglutide: 3.7%). Serious AEs were reported more frequently by patients receiving LY05008 (4.1%) than in those receiving dulaglutide (3.7%).¹

"In Chinese patients with T2DM following multiple subcutaneous injections, efficacy equivalence was achieved between LY05008 and dulaglutide with respect to change from baseline in HbA_1C reduction to week 24," the study authors concluded. "Comparable effects in safety and immunogenicity profiles were observed between the 2 groups."¹

REFERENCES

1. Liu L, Cheng Z, Wang L, et al. Efficacy and Safety of Dulaglutide Biosimilar LY05008 Versus the Reference Product Dulaglutide (Trulicity) in Chinese Adults With Type 2 Diabetes Mellitus: A Randomized, Open-Label, Active Comparator Study. J Diabetes. 2025;17:e70077. doi:10.1111/1753-0407.70077

2. Eli Lilly & Co. FDA Approves Trulicity™ (dulaglutide), Lilly's Once-Weekly Therapy for Adults with Type 2 Diabetes. September 18, 2014. Accessed August 20, 2025. https://investor.lilly.com/news-releases/news-release-details/fda-approves-trulicitytm-dulaglutide-lillys-once-weekly-therapy

3. Fala L. Trulicity (Dulaglutide): A New GLP-1 Receptor Agonist Once-Weekly Subcutaneous Injection Approved for the Treatment of Patients with Type 2 Diabetes. Am Health Drug Benefits. 2015;8(Spec Feature):131-134.

4. Boan Biotech. Boan Biotech Announces Publication of Phase 1 Clinical Study Results of BA5101 in the Journal of Expert Opinion on Biological Therapy. News release. March 15, 2023. Accessed August 20, 2025. https://www.boan-bio.com/en/info.php?id=197

5. Boan Biotech. Boyouping®, China’s First Locally Developed Dulaglutide Injection, Approved for Marketing. News release. August 8, 2025. Accessed August 20, 2025. https://www.boan-bio.com/en/info.php?id=384