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

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

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

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 ...

Henlius and Organon announced the European Medicines Agency validates filing for Perjeta® (pertuzumab) Biosimilar Candidate HLX11 ...

Trastuzumab, tested only as a single agent, has been shown to achieve 7% response in heavily pretreated patients with AOC with 3+ and 2+ HER2 immunostaining by immunohistochemistry (IHC).

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 ...

Subcutaneous administration of trastuzumab and pertuzumab significantly ... The FDA has approved two new biosimilars of denosumab for all indications of the reference medications Prolia and ...

To date, the company's launched products include HANLIKANG (rituximab), the first China-developed biosimilar, HANQUYOU (trastuzumab, trade name: HERCESSI in the U.S., Zercepac in Europe), a China ...

To date, the company's launched products include HANLIKANG (rituximab), the first China-developed biosimilar, HANQUYOU (trastuzumab, trade name: HERCESSI in the U.S., Zercepac in Europe), a China ...