Semaglutide biosimilar study compares pharmacokinetics, safety, and immunogenicity to Ozempic® in healthy adults

The emergence of highly effective GLP-1 receptor agonists like semaglutide (Ozempic®) has revolutionized treatment for type 2 diabetes and obesity. However, high costs and patent protections limit widespread access. The development of biosimilar versions is crucial for increasing affordability and patient access, fostering market competition, and expanding the reach of these life-changing therapies. Biosimilars must demonstrate high similarity in pharmacokinetics (PK), safety, and immunogenicity to the reference product, ensuring equivalent efficacy and safety profiles for patients.

This randomized, open-label, single-dose, parallel-controlled study compared an investigational semaglutide injection to Ozempic® injection 0.25mg via abdominal subcutaneous (SC) administration in healthy adult subjects. Participants were screened for up to 2 weeks and then randomly assigned 1:1 to either the experimental or active comparator group. Following a single dose, subjects underwent a 5-week follow-up period. The primary objectives were to assess pharmacokinetic similarity, safety, and immunogenicity profiles between the two semaglutide formulations.