Blog Big Molecule Watch October 28, 2020

FDA Deferring Action on Spectrum’s ROLONTIS Application As A Result of COVID-19 Related Travel Restrictions

On Monday, Spectrum Pharmaceuticals announced that the FDA was reportedly unable to conduct its required inspections of Spectrum’s Hanmi Bioplant due to travel restrictions related to the COVID-19 pandemic, and that as a result, the FDA was deferring action on the company’s Biologics License Application for ROLONTIS (eflapegrastim) until the inspections can be completed.  President and CEO of Spectrum Joe Turgeon said that the company is “actively working with the FDA to find a way to expedite the plant inspection” and is “eager to assist the FDA in completing their assessment as soon as possible.”

While similar inspection delays have been reported by Zosano and Intercept, we are not aware of any instances in which the FDA has deferred action on biosimilar applications due to COVID-related travel restrictions.

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