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

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 ...

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 ...

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 ...

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 ...

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

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).

At the same time, 90% of U.S. prescriptions are either generics or biosimilars saving the U.S. healthcare system $445 billion in 2023 alone. Despite these achievements, there are important reforms ...

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