Shots:

• The pooled data from 3 randomized controlled trials on biosimilar Udenyca demonstrated similar immunogenicity to reference Neulasta. The studies were also designed to assess PK & PD similarity
• In immunogenicity study, the incidence of treatment-emergent ADAs 32.2% (39) vs 23.9% (28) & persistent ADAs with measurable titer (9.8% vs 5.0%)
• The safety profiles were consistent with a pegfilgrastim safety profile & were unaffected by the presence of ADA, AEs (89.7% vs 92.9%). In a pooled analysis, the incidence of treatment-emergent ADAs was comparable with ADAs detected in 31.6% (72) vs 29.3% (76). In the PK & PD studies, treatment-emergent ADAs were detected in (28.6% vs 33.3%) & (30.0% vs 34.6%)

Ref: Center for Biosimilars | Image: Coherus