FDA provides CRL rejecting Amgen’s application for biosimilar trastuzumab ABP 980, filed August 2017. Amgen states “we do not expect this to impact our US launch plans.”
Product specific reports based on extracts from our BioBlast™ database
aflibercept | Eylea® | Regeneron
bevacizumab | Avastin® | Roche/Genentech
cetuximab | Erbitux® | BMS/Merck
darbepoetin | Aranesp® | Amgen
denosumab | Prolia®/Xgeva® | Amgen
eculizumab | Soliris® | Alexion
filgrastim (GCSF) | Neupogen® | Amgen
golimumab | Simponi® | Janssen
infliximab | Remicade® | Johnson & Johnson
natalizumab | Tysabri® | Biogen/Elan
omalizumab | Xolair® | Genentech / Novartis
pegfilgrastim | Neulasta® | Amgen
pembrolizumab | Keytruda® | Merck
ranibizumab | Lucentis® | Genentech
rituximab | Rituxan®/MabThera® | Genentech/Biogen
tocilizumab | Actemra® | Roche
trastuzumab | Herceptin® | Roche/Genentech