Hanmi Pharm: US Partner Spectrum Resubmits FDA Approval Application for 'Rolontis' Sales

Review Period 6 Months... Pyeongtaek Bio Plant Review Also

Hanmi Pharm Rolontis.

[Asia Economy Reporter Lee Gwan-joo] Spectrum, a partner company of Hanmi Pharmaceutical, announced on the 18th that it has resubmitted a Biologics License Application (BLA) for the long-acting neutropenia treatment biologic drug 'Rolontis' to the U.S. Food and Drug Administration (FDA).

This application follows improvements addressing the Complete Response Letter (CRL) received from the FDA in August last year regarding manufacturing facility enhancements. The FDA is expected to review the application over approximately six months. During this period, the FDA will also conduct an inspection of Hanmi Pharmaceutical’s Pyeongtaek Bio Plant, where the raw materials for Rolontis are produced.

Tom Lee, President of Spectrum, stated, “Spectrum is making significant progress not only on the Rolontis BLA submission but also on the approval of the New Drug Application (NDA) for another innovative anticancer drug, Poziotinib, which is a core business goal. Based on the reorganization of company resources and strengthening of strategic partnerships, we will do our utmost to advance our mission.”

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