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Table 3 Rates of FN by cycle following treatment (FAS—As Randomized)

From: Clinical confirmation to demonstrate similarity for a biosimilar pegfilgrastim: a 3-way randomized equivalence study for a proposed biosimilar pegfilgrastim versus US-licensed and EU-approved reference products in breast cancer patients receiving myelosuppressive chemotherapy

Cycle Proposed biosimilar pegfilgrastim (APO-Peg) US-licensed pegfilgrastim reference product (US-Neulasta®) EU-approved pegfilgrastim reference product (EU-Neulasta®) Total
Cycle 1
 n/N (%) 15/294 (5.1) 6/148 (4.1) 5/147 (3.4) 26/589 (4.4)
 95% CI 2.9–8.3 1.5–8.6 1.1–7.8 2.9–6.4
Cycle 2
 n/N (%) 0/288 (0.0) 1/146 (0.7) 0/144 (0.0) 1/578 (0.2)
 95% CI 0.0–1.3 0.0–3.8 0.0–2.5 0.0–1.0
Cycle 3
 n/N (%) 0/285 (0.0) 0/146 (0.0) 1/144 (0.7) 1/575 (0.2)
 95% CI 0.0–1.3 0.0–2.5 0.0–3.8 0.0–1.0
Cycle 4
 n/N (%) 0/284 (0.0) 0/144 (0.0) 0/144 (0.0) 0/572 (0.0)
 95% CI 0.0–1.3 0.0–2.5 0.0–2.5 0.0–0.6
Cycle 5
 n/N (%) 2/276 (0.7) 0/143 (0.0) 0/142 (0.0) 2/561 (0.4)
 95% CI 0.1–2.6 0.0–2.5 0.0–2.6 0.0–1.3
Cycle 6
 n/N (%) 0/270 (0.0) 0/143 (0.0) 0/139 (0.0) 0/552 (0.0)
 95% CI 0.0–1.4 0.0–2.5 0.0–2.6 0.0–0.7
Overall
 n/N (%) 17/294 (5.8) 7/148 (4.7) 5/147 (3.4) 29/589 (4.9)
 95% CI 3.4–9.1 1.9–9.5 1.1–7.8 3.3–7.0