Number 5: The approvals for Celltrion's denosumab-bmwo (Stoboclo and Osenvelt) mark the third FDA green light for a ...

February brought policy updates and several biosimilar approvals, including the first FDA approval for an insulin aspart ...

Celltrion received recommendations of approval from the European drug regulator for four of its biosimilar products ... of the European Medicines Agency (EMA) recommended for market authorization ...

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 ...

EU rules that all biosimilars are interchangeable The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have, meanwhile, published a statement confirming that all EU ...

FYB202/Otulfi ® (ustekinumab-aauz), a biosimilar to Stelara®, launched in the United States and the European Union FYB202/Otulfi ® is now commercially available in both subcutaneous and intravenous ...

In accordance with the biosimilar guidelines of NMPA, EMA, and USFDA, HLX15 is being developed following the principles of stepwise development. HLX15 and reference daratumumab are considered ...

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 ...

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 ...