Number 5: The approvals for Celltrion's denosumab-bmwo (Stoboclo and Osenvelt) mark the third FDA green light for a biosimilar to treat osteoporosis and bone metastases. Number 4: February brought ...

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

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 ...

In acknowledgment of the fact that the EMA does not make recommendations on whether a biosimilar should be used interchangeably with its reference medicine, or with other biosimilar medicines, the ...

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 ...

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 ...

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 ...

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 currently in ...

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 ...