Herceptin biosimilars While the pembrolizumab copy was eye-catching, the firm’s next big biosimilar launch in Europe is a version of Roche’s Herceptin (trastuzumab).

The inquiry is the latest effort by the European Commission and European countries to scrutinize potential antitrust behavior ...

Monoclonal antibodies lead biosimilar approvals because of their large market size, well-defined regulatory pathways, and ...

Shanghai Henlius Biotech, Inc. (2696) and Organon (NYSE: OGN) today announced that the European Medicines Agency (EMA) has valida ...

Ontruzant, the first biosimilar version of Roche’s Herceptin (trastuzumab) in Europe has been launched in the UK by MSD. Developed by Korean biosimilar specialists Samsung Bioepsis, MSD is the ...

In 2022, Henlius entered into a license and supply agreement with Organon, granting Organon the exclusive commercialization rights to two biosimilar candidates, including HLX11. The agreement covers ...

Introduction Biosimilar monoclonal antibodies (mAbs) are biologic drugs designed to be highly similar to already approved reference monoclonal ...

The FDA granted orphan drug designation to HLX22 for gastric cancer, advancing global phase 3 trials to improve first-line ...

Background: Variable rates of HER2 protein overexpression and gene amplification have been reported in advanced ovarian cancers (AOC). Trastuzumab, tested only as a single agent, has been shown to ...

Dublin, Feb. 12, 2025 (GLOBE NEWSWIRE) -- The "Adalimumab, Infliximab, Etanercept and Trastuzumab Biosimilars Market Opportunities and Strategies to 2033" report has been added to ...