US-Korea 'Rollontis', FDA Approval Process Officially Begins

[Asia Economy Reporter Lee Chun-hee] Spectrum, a partner company of Hanmi Pharmaceutical, has officially begun the Biologics License Application (BLA) review for the neutropenia treatment drug 'Rolontis' resubmitted to the U.S. Food and Drug Administration (FDA).

On the 11th (local time), Spectrum announced that the FDA approved the BLA for Rolontis and has entered the official review process for marketing authorization. Spectrum initially submitted the approval application to the FDA in August last year but was requested to supplement manufacturing facility information and resubmitted the application on the 18th of last month.

Accordingly, under the Prescription Drug User Fee Act (PDUFA), the FDA is expected to decide on the final approval by September 9. During this period, the FDA will also conduct an inspection of Hanmi Pharmaceutical’s Pyeongtaek Bio Plant, which produces the raw materials for Rolontis.

Tom Lee, President of Spectrum, said, “The FDA’s approval of the Rolontis BLA submission is an important milestone,” adding, “We are actively cooperating with the FDA review process and look forward to the final approval of Rolontis.” Kwon Se-chang, CEO of Hanmi Pharmaceutical, also stated, “We have officially entered the final stage for FDA approval of Rolontis,” and “We will work closely with our partner Spectrum to ensure the successful marketing approval of Rolontis.”

This content was produced with the assistance of AI translation services.