The U.S. Food and Drug Administration has temporarily postponed the approval for the novel long-acting neutropenia drug, Rolontis (ingredient: eflapegrastim), which Hanmi Pharmaceutical licensed out to Spectrum Pharmaceuticals.

Hanmi Pharmaceutical said that FDA found it necessary to inspect the company’s bio plant in Korea before the U.S. agency gives its nod, but the schedule was delayed due to restrictions on overseas business trips.

Spectrum Pharmaceuticals also said that it is actively working with the FDA to find a way to perform an inspection of Hanmi's bio plant.

FDA has completed its inspections of manufacturing facilities and packaging sites of Rolontis, as well as the head office of Spectrum Pharmaceuticals, leaving the Hanmi's bio plant as the last facility to see for its approval. The companies also submitted documents requested by the FDA to review before giving the permit.

“FDA noticed Spectrum Pharmaceuticals that the recent delay is not a rejection or complete response letter, but a defer action, meaning all other steps required for approval have been completed,” Hanmi Pharmaceutical said. “Rolontis will receive approval from the FDA as soon as the inspection is done.”

The inspection was originally planned for March 2020, but the date has been pushed back twice due to the global Covid-19 pandemic. Nor could the inspection be conducted before the deadline, Oct. 24, due to Covid-19.

In addition to Rolontis, there have been many cases of delay in the approval of drugs with new manufacturing facilities outside the U.S., for which the FDA issued new guidance in August.

Rolontis’ domestic approval is going through regulatory inspection smoothly. Hanmi Pharmaceutical applied for the approval of Rolontis to the Ministry of Food and Drug Safety, and the Korean regulator has recently completed inspecting Hanmi's bio plant.

An official of Hanmi Pharmaceutical added that Rolontis is expected to receive the domestic approval within this year.