Skip to main content

Table 6 Key studies of biosimilar filgrastim that demonstrated clinical equivalence to the reference drug

From: What do oncologists need to know about biosimilar products?

Active substance Brand name Key studies of biosimilar filgrastim demonstrating clinical equivalence to reference drug
Filgrastim-XM02 Ratiograstim/Tevagrastim/Biograstim Multinational, multicenter, randomized, controlled phase III study; breast cancer patients receiving docetaxel/doxorubicin chemotherapy (n = 348)
Reference drug, Neupogen [47]
Multinational, multicenter, randomized, controlled phase III study; lung cancer patients receiving platinum based chemotherapy (n = 240)
Reference drug, Neupogen [48]
Multinational, multicenter, randomized, controlled phase III study; patients with non-Hodgkin lymphoma receiving chemotherapy (n = 92)
Reference drug, Neupogen [49]
Filgrastim-EP2006 Filgrastim Hexal/Zarzio Multinational, multicenter, randomized, controlled phase III study in chemo-naïve breast cancer patients receiving neoadjuvant/adjuvant docetaxel, doxorubicin, and cyclophosphamide chemotherapy (n = 218)
Reference product, Neupogen [50]
Filgrastim-PLD108 Nivestim Multicenter, randomized, controlled phase III study; breast cancer patients treated with doxorubicin and docetaxel in neoadjuvant/adjuvant or first-line metastatic setting (n = 279)
Reference drug, Neupogen [51]
  1. PK pharmacokinetics; PD pharmacodynamics