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

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 ...

CHMP Adopts Positive Opinion for Aflibercept, Pegfilgrastim Biosimilars: On January 30, 2025, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP ...

Biocon Biologics Ltd on Monday announced that it has received approval from the European Medicines Agency (EMA) to manufacture biosimilar Bevacizumab at its new multi-product monoclonal antibodies ...

Global biosimilar regulatory harmonization will be needed to reduce development costs and improve patient access, despite ...

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 ...

The biosimilar received marketing authorization from the EMA and the FDA in September 2024, and from Health Canada and the UK's MHRA in January 2025. Formycon AG (FSE: FYB) is a leading ...

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 ...