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

The European Medicines Agency’s (EMA’) human medicines committee (CHMP) has recommended two new medicines and three ...

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 ...

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

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

Two further biosimilars, FYB202/ustekinumab and FYB203/aflibercept, have been approved by the FDA, EMA, and MHRA; FYB202 is also approved in Canada. Another four biosimilar candidates are ...

today announced that the European Medicines Agency (EMA) has validated the marketing authorization application (MAA) for HLX11, an investigational biosimilar of Perjeta ® (pertuzumab).

today announced that the European Medicines Agency (EMA) has validated the marketing authorization application (MAA) for HLX11, an investigational biosimilar of Perjeta® (pertuzumab). Pertuzumab ...

today announced that the European Medicines Agency (EMA) has validated the marketing authorization application (MAA) for HLX11, an investigational biosimilar of Perjeta ® (pertuzumab).