The European Medicines Agency approved Afqlir and Opuviz to treat age-related macular degeneration while reiterating its ...

Committee for Human Medicinal Products (CHMP) recommended approval of five novel medicines at its September meeting ...

On August 15, 2024, Alvotech and Advanz Pharma announced that the European Medicines Agency (EMA) has accepted a Marketing Authorization Application for AVT06, Alvotech’s biosimilar of low dose ...

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 ...

OPUVIZ™, a biosimilar referencing Eylea1 (aflibercept), is Samsung Bioepis and Biogen’s second ophthalmology biosimilar to be recommended for marketing authorization by the European Medicines Agency ...

HANSIZHUANG ® (serplulimab) was the first anti-PD-1 monoclonal antibody (mAb) approved for first-line treatment of ES-SCLC – ...

A biosimilar, according to the European Medicines Agency (EMA), is a biological medicine that is highly similar to one already approved in the EU. This means patients can expect the same safety and ...

In terms of its pipeline, the European Medicines Agency ("EMA") has accepted Alvotech's filing for approval for its Eylea biosimilar, AVT06, while a filing for Prolia biosimilar is expected this year.

Alteogen announced that it has applied for marketing authorization in Korea for ALT-L9, an aflibercept biosimilar ...

Of the patients in the study, 16.41% received originator products, 87.22% received biosimilars, 3.6% received both a biosimilar and an originator, and 6.2% were treated with both adalimumab and ...

OPUVIZ, a biosimilar referencing Eylea1 (aflibercept), is Samsung Bioepis and Biogen's second ophthalmology biosimilar to be recommended for marketing authorization by the European Medicines Agency IN ...