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Application for biosimilar Neulasta accepted

Jan 5, 2015

FDA accepts Apotex’s s351(k) application for biosimilar Neulasta.

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Product specific reports based on extracts from our BioBlast® database

adalimumab | Humira® | AbbVie

aflibercept | Eylea® | Regeneron

bevacizumab | Avastin® | Roche/Genentech

cetuximab | Erbitux® | BMS/Merck

daratumumab | Darzalex® | J&J

darbepoetin | Aranesp® | Amgen

denosumab | Prolia®/Xgeva® | Amgen

dupilumab | Dupixent® | Sanofi-Aventis

eculizumab | Soliris® | Alexion

etanercept | Enbrel® | Amgen

faricimab | Vabysmo® | Roche

filgrastim (GCSF) | Neupogen® | Amgen

golimumab | Simponi® | Janssen

guselkumab | Tremfya® | Janssen

infliximab | Remicade® | Johnson & Johnson

ixekizumab | Taltz® | Eli Lilly

lecanemab | Leqembi® | Eisai/Biogen

liraglutide | Victoza® /Saxenda® | Novo Nordisk

natalizumab | Tysabri® | Biogen/Elan

nivolumab | Opdivo® | BMS

olaparib | Lynparza® | AstraZeneca/Merck

omalizumab | Xolair® | Genentech / Novartis

pegfilgrastim | Neulasta® | Amgen

pembrolizumab | Keytruda® | Merck

pertuzumab | Perjeta® | Roche

ranibizumab | Lucentis® | Genentech

regdanvimab | Regkirona® | Celltrion

risankizumab | Skyrizi® | AbbVie

rituximab | Rituxan®/MabThera® | Genentech/Biogen

secukinumab | Cosentyx® | Novartis

semaglutide | Wegovy®/Ozempic® | Novo Nordisk

tocilizumab | Actemra® | Roche

trastuzumab | Herceptin® | Roche/Genentech

ustekinumab | Stelara® | Johnson & Johnson/Janssen

vedolizumab | Entyvio® | Takeda

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