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 ...

Shanghai Henlius Biotech and Organon (OGN) announced that the European Medicines Agency has validated the marketing authorization application ...

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

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

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

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

Shanghai Henlius Biotech, Inc. (2696.HK) announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for HLX22, the company's innovative anti-HER2 monoclonal ...

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

Trastuzumab biosimilar manufacturing cost estimates – Commission relied on a body of knowledge that provides a calculation algorithm to estimate the manufacturing cost of Trastuzumab biosimilars; ...

Objectives: Biosimilars offer a promising solution to challenges related to healthcare budget sustainability. However, limited patient awareness and understanding often hinder their timely adoption.

STEQEYMA ®, one of the first-wave biosimilars to STELARA ®, is now available in the U.S. Approved for the same indications as the reference product, STEQEYMA will be priced with a wholesale ...