April 26, 2024

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[THE INVESTOR] Celltrion has faced a setback in bringing its two biosimilar products to the US market as authorities have decided not to approve them for now.

The Korean company said on April 5 that the US Food and Drug Administration has issued a complete response letter for its Biologic License Applications for Truxima, its version of Roche’s Rituxan and Herzuma, a biosmilar referencing Roche’s Herceptin, which were expected to win marketing authorization before June this year.

“We are committed to working with the regulatory agency to fully resolve all outstanding issues with an aim to receive approval this year,” the company said in a statement on its website.

The FDA action comes as a follow-up measure of a warning letter that the agency handed down in January, citing production facility and manufacturing process issues, following an inspection of the company’s facility in Incheon, in May and June last year.

In the previous letter, the FDA stated it found “significant violations of current good manufacturing practice regulations for finished pharmaceuticals.”

Truxima and Herzuma were granted EU approval in 2017 and 2018, respectively.

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