NIVESTYM Safety Data in Support of Biosimilarity

Data in healthy volunteers in support of biosimilarity
NIVESTYM showed comparable incidence of TEAEs in a randomized immunogenicity study in healthy volunteers2
 
NIVESTYM showed comparable incidence of AESIs in an immunogenicity study in healthy volunteers2
Frequency of AESIs (≥5%)
There were no deaths in this study. Three subjects discontinued the study due to an AE: 2 subjects in the NIVESTYM group (diverticular perforation unrelated to study drug; back pain) and 1 subject in the Neupogen group (back pain).