April 20, 2024

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[THE INVESTOR] Celltrion said Sept. 16 that the US Food and Drug Administration has given its OK to the Korean biopharmaceutical firm’s manufacturing facility after re-inspection, clearing a year-long problem that hampered the approval of its biosimilar products.

The FDA classified the firm’s production site in Incheon as “voluntary action indicated,” in an Establishment Inspection Report, which summarizes its findings after inspection in July. 

The status means that “objectionable items were found, but no action is required on the part of the authority. All of the company’s actions are on a voluntary basis,” according to FDA’s website.

“We believe the issues related to Current Good Manufacturing Practice are resolved with the FDA’s final inspection report,” the company said in a statement.

Celltrion has struggled with addressing its manufacturing deficiencies that first emerged during an inspection in May last year, which drew a series of warnings from the FDA.

In August, the Korean firm received a Form 483, notice of adverse finding, from the US agency following two complete response letters in April, in which the agency declined to approve Celltrion’s biosimilars -- Truxima and Herzuma. The company attributed the rejection to a warning letter for the site in January. Last September, the site also received another Form 483.

Celltrion’s partner Teva was also hit by US regulatory concerns about the manufacturing process at its Incheon plant, suffering a delay in receiving marketing authorization for its candidate for migraines as the site produces an active pharmaceutical ingredient for the drug.

With the outstanding observations being lifted, Teva won approval for the treatment Ajovy on Sept. 15.

FDA’s latest report also paves the way for Celltrion’s pending biologics license applications for Truxima, its version of Roche’s Rituxan and Herzuma, a biosimilar referencing Roche’s Herceptin.

The US health regulator said on Sept. 12 it will hold an advisory committee meeting in October for Truxima, hinting at a final decision to allow sales.

Celltrion expects Herzuma will also clear the final regulatory hurdle before the year ends.

By Park Han-na (hnpark@heraldcorp.com)