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 ...

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 ...

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 ...

“We have a longstanding and productive partnership with Amneal, and we are pleased to be advancing these two important products to the U.S. biosimilar market. We remain focused on our globalization ...

This milestone underscores our commitment to providing cost-effective, high-quality biosimilars to patients ... and European Medicines Agency (EMA). The safety profile of YESINTEK was similar ...

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 ...