Celltrion Healthcare has reportedly filed an IND application to the FDA for a phase III clinical trial to demonstrate...
Ph III trial shows Qila’s denosumab biosimilar improves bone mineral density
It has been reported that a Ph III clinical trial of Qilu Pharmaceutical’s biosimilar denosumab, QL1206, showed...
Biocon biosimilars revenue up 29% in advance of close of Viatris deal
Biocon announced that its Q1 2022 revenue for biosimilars was up 29%. This comes in advance of Biocon’s subsidiary...
Viatris (Mylan) seeks PBS listng for etanercept biosimilar
Alphapharm (Viatris’ Australian subsidiary) has its etanercept biosimilar, Nepexto®, on the agenda for the November...
Prestige and Intas to commercialise bevacizumab biosimilar in US, EU & elsewhere
Prestige Biopharma announced an exclusive partnership with Intas and its affiliate Accord Healthcare to commercialise...
TGA approves Henlius/Cipla trastuzumab biosimilar
Henlius Biotech announced that the TGA has approved Henlius’ trastuzumab biosimilar, which will be marketed in...
FDA accepts ABLA for natalizumab biosimilar
Sandoz announced that the FDA has accepted its ABLA for a natalizumab biosimilar developed by Polpharma Biologics for...
FDA accepts sBLA for 100mg/mL Hyrimoz®
Sandoz announced that the FDA has accepted its sBLA for a high-concentration citrate-free formulation (100mg/mL) of...
Alvotech commences Ph I trials of AVT03 (denosumab) in male subjects
Alvotech announced that it has initiated a pharmacokinetic study for AVT03 (denosumab, biosimilar to Prolia®/Xgeva®). ...
Novartis provides update on Sandoz and earnings data
Novartis published its financial results, reporting a 1% decrease USD (5% increase cc) in Q2 2022 sales over Q2 2021,...
Poland’s URPL approves IND for Celltrion’s CT-P47 (biosimilar tocilizumab)
Korea Biomedical Review reported that Celltrion has received approval from Poland’s Pharmaceutical and Medical...
J&J report a 53% decrease in Remicade® exports
Johnson & Johnson reported a 53% YoY decrease in exports of Remicade® (infliximab) from the US suggesting a very...
Erasca and Eli Lilly sign clinical trial collaboration and supply agreement for Erbitux® (cetuximab)
Erasca and Eli Lilly announced that they have entered into a clinical trial collaboration and supply agreement for...
Hikma and Celltrion enter into commercialisation agreement for YuflymaTM
Hikma Pharmaceuticals announced that it has entered into a commercialisation agreement with Celltrion in relation to...
EMA accepts MAA for Polpharma’s biosimilar natalizumab
Polpharma Biologics announced that the EMA has accepted its MAA for its biosimilar natalizumab for highly active...
Roche publishes eight-year data on Perjeta® based regimen for breast cancer
Roche reported that eight-year data from its Ph III trials of Perjeta® (pertuzumab) in combination with Herceptin®...