BioFactura Reports P-I Study Results of BFI-751 (biosimilar, ustekinumab)
Shots:
- The P-I study results published in the peer-reviewed journal, Clinical Pharmacology in Drug Development evaluating PK profiles of BFI-751 vs EU & US ustekinumab in 216 healthy adult volunteers
- All 3 treatments met the standard BE criteria that is CI: 90% of the geometric mean ratios of AUC (0-infinity), AUC (0 to Cmax), and maximum concentration are completely within the acceptance interval
- No differences in the safety, immunogenicity & tolerability profiles were seen with no difference in the overall incidence of injection site reactions after dosing among treatment groups. BioFactura & CuraTeQ sign exclusive license for BFI-751, a biosimilar to Stelara on July 2023
Ref: Cision PR Web | Image: Biofactura
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