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

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

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

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 ...

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

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 ...

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 ...

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 ...