Biosimilar Clinical Trial Updates

On May 4, 2023, Alvotech announced the initiation of a confirmatory patient study for AVT05, a biosimilar candidate to Simponi and Simponi Aria (golimumab).  The clinical study will compare the efficacy, safety, and immunogenicity of AVT05 and Simponi in adult patients with moderate to severe rheumatoid arthritis.  Per the announcement, “the primary outcome measure [of the study] will be to demonstrate comparative efficacy of AVT05 with Simponi at week 16 based on the change from baseline on a standardized Disease Activity Standard score (DAS28-CRP) which assesses the severity of rheumatoid arthritis using clinical and laboratory data.”

On May 15, 2023, Boan Biotech announced the completion of patient enrollment for a Phase III clinical trial of the company’s Dulaglutide Injection (BA5101) in China.  BA5101 is a biosimilar of Trulicity, used for glycemic control in adults with insufficiently controlled type 2 diabetes mellitus.  The Phase III clinical trial will compare the clinical efficacy and safety of BA5101 with Trulicity in Chinese adult patients with type 2 diabetes.  It will further compare the efficacy, safety, immunogenicity and pharmacokinetics of BA5101 with Trulicity after multiple subcutaneous injections in these patients.