BioBlast w/e 01 Dec 23
01 DEC 2023 | US | Celltrion Files BLA for Interchangeable Prolia® (Denosumab) Biosimilar with the FDA The Korea Biomedical Review reported that Celltrion has submitted an application for marketing authorisation to the FDA for CT-P41, its...
BioBlast w/e 24 Nov 23
24 NOV 2023 | Celltrion Applies For EU Approval of CT-P43, Biosimilar to Regeneron’s Eylea® (aflibercept) Celltrion revealed in a corporate filing with the Repository of Korea’s Corporate Filings (DART) that it has applied for marketing...
BioBlast w/e 17 Nov 23
16 NOV 2023 | US | Approval Alert: AZ’s Truqap® (capivasertib) plus Faslodex® FDA Approved to Treat Advanced HR-positive Breast Cancer AstraZeneca (AZ) announced the FDA approved its Truqap® (capivasertib) in combination with Faslodex...
BioBlast w/e 10 Nov 23
10 NOV 2023 | EU | CHMP Positive Opinion for 8mg Eylea® (Aflibercept) Bayer announced that the EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of 8mg Eylea® (aflibercept) intravitreal injection for the...
BioBlast w/e 03 Nov 23
01 NOV 2023 | EU | Fresenius Kabi’s Launches First EU Tocilizumab Biosimilar Fresenius Kabi announced it has launched Tyenne®, the first EC-approved biosimilar to Roche’s Actemra®/RoActemra® in the EU. Tyenne® was approved by the EC on 19...
BioBlast w/e 27 Oct 23
27 OCT 2023 | US | Sanofi to Spin-Off Consumer Business and Focus on Biopharma by End Q4 2023 Sanofi announced that it will separate its Consumer Healthcare Business as soon as the end of Q4 2024, creating a publicly listed company headquartered...
BioBlast w/e 23 Oct 23
23 OCT 2023 | US | Approval Alert: FDA Approves Celltrion’s Zymfentra® (infliximab-dyyb), Biosimilar to Janssen’s Remicade®, and the First Approved SC Infliximab Celltrion announced that the FDA has approved its subcutaneous formulation of...
BioBlast w/e 15 Oct 23
15 OCT 2023 | Samsung Bioepis Reveals SB16 (denosumab) Study Results at ASBMR Samsung Bioepis presented new data on its SB16 (denosumab, biosimilar to Amgen’s Prolia®) at the American Society for Bone and Mineral Research (ASBMR) 2023 Annual...
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
dupilumab | Dupixent® | Sanofi-Aventis
eculizumab | Soliris® | Alexion
filgrastim (GCSF) | Neupogen® | Amgen
golimumab | Simponi® | Janssen
guselkumab | Tremfya® | Janssen
infliximab | Remicade® | Johnson & Johnson
ixekizumab | Taltz® | Eli Lilly
natalizumab | Tysabri® | Biogen/Elan
omalizumab | Xolair® | Genentech / Novartis
pegfilgrastim | Neulasta® | Amgen
pembrolizumab | Keytruda® | Merck
ranibizumab | Lucentis® | Genentech
regdanvimab | Regkirona® | Celltrion
risankizumab | Skyrizi® | AbbVie
rituximab | Rituxan®/MabThera® | Genentech/Biogen
secukinumab | Cosentyx® | Novartis
tocilizumab | Actemra® | Roche
trastuzumab | Herceptin® | Roche/Genentech
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