Official websites use .gov
A
.gov website belongs to an official
government organization in the United States.
Secure .gov websites use HTTPS
A lock (
) or https:// means you've safely
connected to the .gov website. Share sensitive
information only on official, secure websites.
The human PK assay prototype was established by reformatting the nonclinical PK assay for use with human serum matrix. The standard curve comparison of the biosimilar, the FDA-licensed, and EU-authorized reference products in the human PK prototype assay are presented, with the profiles showing the 3 products were comparable within the method. Mean (n = 2), + SD plotted; CVs ≤ 3%. Recoveries for the standard curve points were within ± 14% of nominal.
