Table 1.
Biosimilars of pegfilgrastim approved in Europe and the US
| Brand name | Manufacturer | Registration trial | EMA approval | FDA approval |
|---|---|---|---|---|
| Pelgraz® | Accord Healthcare |
Desai et al. 2018 [56] Phase III randomised, assessor-blinded, multicentre study on 589 breast cancer patients with reference arms of US–Neulasta and EU–Neulasta |
September 2018 | |
| Udenyca® | Coherus | Dose–response triala | September 2018 | November 2018 |
| Fulphila® | Mylan |
Waller et al. 2019 [57] Phase III randomised, assessor-blinded study on 194 breast cancer patients with reference arm of EU–Neulasta |
November 2018 | June 2018 |
| Pelmeg® | Cinfa Biotech/Mundipharma | Dose-response triala | November 2018 | |
| Ziextenzo® | Sandoz |
Harbeck et al. 2016 [58] Phase III randomised, assessor-blinded, multicentre study on 316 breast cancer patients with reference arm of EU–Neulasta |
November 2018 | November 2019 |
| Grasustek® | Juta Pharma |
Grasustek (EPAR)b Phase III randomised, assessor-blinded, multicentre study on 254 breast cancer patients with reference arm of EU–Neulasta |
April 2019 | |
| Pegfilgrastim Mundipharma® | Mundipharma | Dose-response triala | December 2019 |
aAs reported in EMA EPAR available at https://www.ema.europa.eu
bEMA Grasustek EPAR. Available at https://www.ema.europa.eu/en/medicines/human/EPAR/grasustek
EMA European Medicines Agency, EPAR European public assessment report, FDA The Food and Drug Administration