First Biosimilar Neulasta In Final Stages Of EMA Review Process
Executive Summary
A biosimilar version of Amgen’s Neulasta has yet to be approved in the EU but one such product is in the later stages of review at the European Medicines Agency.
You may also be interested in...
EU CHMP Finalizes Outstanding Issues On Aimovig And Symproic
EU regulators meeting in London are finalizing the outstanding questions they have for companies whose products are approaching the final stages of the approval process.
EU CHMP Finalizes Outstanding Issues On Aimovig And Symproic
EU regulators meeting in London are finalizing the outstanding questions they have for companies whose products are approaching the final stages of the approval process.
Rolontis Leads Hanmi’s Global Ambitions As ADVANCE Phase III Endpoint Met
Rolontis, a novel, long-acting granulocyte colony-stimulating factor (G-CSF) licensed out to Spectrum Pharmaceuticals, has become Hanmi Pharmaceuticals' first drug developed with its proprietary platform to approach the regulatory filings stage in global markets.