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] |