SHANGHAI, China & JERSEY CITY, NJ, USA I March 28, 2025 I Shanghai Henlius Biotech, Inc. (2696.HK) and Organon (NYSE: OGN) today announced that 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 ...

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

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

Fosun Pharma continues to uphold the internationalization strategy in multiple dimensions, such as innovative R&D, licensing, manufacturing and operations as well as commercialization. In 2024, ...

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 ...

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 ...