The Chinese-developed GLP-1 biosimilar HEC14028 demonstrated pharmacokinetic equivalence to dulaglutide (Trulicity) in 68 healthy subjects, with matching safety profiles and no increased immune reactions.
Bioequivalence confirmed (80-125% range met)The biosimilar HEC14028 matched brand-name dulaglutide for both peak blood levels and total drug exposure, meeting the standard regulatory threshold for pharmaceutical equivalence
What the researchers found
HEC14028 and dulaglutide were pharmacokinetically equivalent: 90% CI of Cmax ratio was 102.9%-122.0% and AUC0-∞ ratio was 97.1%-116.9%, both within the accepted 80-125% bioequivalence range. No grade 3+ adverse events, serious adverse events, or deaths occurred. No incremental immunogenicity with the biosimilar.
Why it matters
Biosimilar GLP-1 drugs could dramatically reduce costs and improve global access to these transformative diabetes treatments, which remain prohibitively expensive for many patients.
The numbers in context
n=68; 1:1 randomization; 0.75 mg single dose; Cmax 90% CI: 102.9-122.0%; AUC0-∞ 90% CI: 97.1-116.9%; no grade 3+ TEAEs
How the study worked
Single-center, randomized, open-label, single-dose, parallel-controlled Phase I trial. 68 healthy Chinese male subjects randomized 1:1 to HEC14028 or dulaglutide (0.75 mg subcutaneous). 14-day screening, 17-day observation, 7-day safety follow-up. Primary endpoints: Cmax and AUC0-∞ with 90% CI within 80-125% bioequivalence range.
What this study cannot tell us
Only healthy male Chinese subjects — results may not fully generalize to other populations, females, or diabetic patients. Single-dose study doesn't capture steady-state pharmacokinetics. Only the 0.75 mg dose tested (not the standard 1.5 mg therapeutic dose). Open-label design. Small sample size (n=68). Safety profile with longer-term use unknown.
How to read the evidence
This is a Phase I randomized PK study — the standard methodology for establishing biosimilar equivalence. The study met its primary endpoints with both PK parameters within the accepted bioequivalence range. However, clinical efficacy and long-term safety still require Phase III trial confirmation.
When this study was published
Published in 2024, this study is part of the early wave of GLP-1 biosimilar development that is expected to transform the market economics of incretin-based therapies in coming years.
The bigger picture
GLP-1 drug costs ($1,000+/month in many markets) are the biggest barrier to their population-level impact. Biosimilar development — already transforming biological drug affordability in oncology and autoimmune disease — is now entering the GLP-1 space. As patents for liraglutide and dulaglutide expire, biosimilars like HEC14028 could reduce costs by 30-80%, making these life-changing medications accessible to millions more patients worldwide. This study provides the pharmacokinetic foundation that biosimilar approval requires.
Questions still open
- Will HEC14028 demonstrate equivalent clinical efficacy (HbA1c reduction, weight loss) in diabetic patients in larger Phase III trials?
- How much could biosimilar GLP-1 drugs reduce treatment costs compared to branded products?
- When will GLP-1 biosimilars become available in major markets like China, Europe, and the US?
Common questions
What is a biosimilar and how is it different from a generic?
Could biosimilars make Ozempic-type drugs more affordable?
Read the original research
A pharmacokinetic study comparing the biosimilar HEC14028 and Dulaglutide (Trulicity®) in healthy Chinese subjects.
Clinical and translational science, 17(4), e13775
Citation
Gao, Xianglei; Di, Yujing; Lv, Yuan; Luan, Yingcai; Xiong, Yang; Xu, Yuli; Li, Yusheng; Guo, Linfeng; Li, Xiaoping; Deng, Li; Zhuang, Yulei; Hou, Jie. (2024). A pharmacokinetic study comparing the biosimilar HEC14028 and Dulaglutide (Trulicity®) in healthy Chinese subjects.. Clinical and translational science, 17(4), e13775. https://doi.org/10.1111/cts.13775