BioBlast w/e 26 May 23
26 MAY 2023 | EU | Celltrion files MAA with EMA for biosimilar to Janssen’s Stelara® (ustekinumab) Korea Biomed has reported that Celltrion filed a marketing authorisation application with the EMA for CT-P43, its biosimilar to Janssen’s Stelara®...
BioBlast w/e 22 May 23
22 MAY 2023 | US | Janssen and Amgen settle Stelara® (ustekinemab) biosimilar patent dispute The US District Court of Delaware has dismissed with prejudice. The parties agreed to dismiss the action with prejudice and each party will bear its...
BioBlast w/e 12 May 23
11 MAY 2023| EU | Celltrion to supply Vegzelma® (bevacizumab) in Italy and Belgium Korea Biomed has reported that Celltrion Healthcare has won bids to supply Vegzelma®, biosimilar to Genentech’s Avastin® (bevacizumab), in Italy and Belgium to...
BioBlast w/e 05 May 23
04 MAY 2023 | CN | Boan Biotech commences phase III clinical trials for Prolia®/Xgeva® (denosumab) biosimilar Luye Pharma announced that it has enrolled its first subject in an international multi-center Phase 3 clinical study for its internally...
BioBlast w/e 28 Apr 23
28 April 2023 | US | FDA advisory committee supports approval of Merck’s Lynparza® (olaparib) combination for first line treatment of prostate cancer Merck announced that the FDA’s Oncologic Drugs Advisory Committee (ODAC) has voted to support...
BioBlast w/e 21 Apr 23
20 April 2023 | CA | New indication alert: Health Canada issues notice of compliance for Regeneron/Sanofi’s Dupixent® (dupilumab) in children > 6 months Sanofi and Regeneron announced that Health Canada issued a Notice of Compliance for...
BioBlast f/e 14 Apr 23
Significant biosimilar activities this fortnight include: 13 April 2023 | US | Alvotech CRL provided to FDA regarding high concentration buffer free biosimilar adalimumab 12 April 2023 | AU | Samsung Bioepis files opposition to Janssen’s...
BioBlast w/e 31 Mar 23: Humira® AU price reduction | EMA recommends Samsung’s EPYSQLI™ eculizumab | US Supreme Court hears Amgen v Sanofi | Eli Lilly $1B mAb manufacture investment in Ireland | Daiichi Enhertu® JP approval | Coya and Dr. Reddy’s ww development agreement … and more!
Significant biosimilar activities this week include:01 April 2023 | AU | Humira® 24.39% PBS price drop 30 March 2023 | EU | EMA CHMP gives nod to Samsung Bioepis’ Epysqli™ eculizumab biosimilar 29 March 2023 | AU | Cipla/Alvotech’s biosimilar...
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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