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

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 ...

The FDA approved another set of denosumab biosimilars, Conexxence/Bomyntra (denosumab-bnht), expanding treatment options for ...

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

I Gedeon Richter Plc. announces today that the European Medicines Agency has accepted Richter’s marketing authorization application (MAA) for ...

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

Biosimilars are essential healthcare equalizers, but their regulation is overly complicated due to lobbying by makers of ...

EMA advisors at the Committee for Medicinal Products for Human Use (CHMP) recommended Sandoz’s adalimumab Humira biosimilar under three brand names – Halimatoz, Hefiya and Hyrimoz. The firm ...

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 ...

A Step Forward in Biosimilars YESINTEK® is designed for ... positive recommendation from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) on December ...

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 ...