Spectrum Pharmaceuticals announced today that an inspection of the Hanmi Bioplant in South Korea will be necessary before the U.S. Food and Drug Administration (FDA) can approve its Biologics License Application (BLS) for ROLONTIS (eflapegrastim). Because of the COVID-19 pandemic, the FDA has not been able to conduct an inspection, and it has decided to defer action on the BLA until it can be completed.
