Hanmi Pharm Co. Ltd

Korea, Republic of

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14th November 2020

Spectrum's Rolontis hits another setback as FDA faces COVID-19 plant inspection backlog

The COVID-19 pandemic has disrupted another biopharma company's plan to launch a new medicine. This time, it's Spectrum Pharmaceuticals' neutropenia candidate Rolontis—and the delay stings particularly for Spectrum after its decision to sell marketed meds and focus on R&D.


The reason for the latest delay? The company licensed the med from South Korea's Hanmi, and FDA officials haven't been able to get to Korea for a final plant inspection due to the pandemic.

While the FDA has completed inspections for manufacturing and packaging sites, the agency has yet to complete an inspection for Hanmi’s bioplant in South Korea thanks to COVID-19 travel restrictions, Korea Biomedical Review reports. The review was initially scheduled for March, but officials had to delay it twice due to the pandemic and couldn’t meet the Oct. 24 deadline.

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