FDA resumes review of Celltrion`s biosimilar Herzuma

[Photo provided by Celltrion]

The U.S. Food and Drug Administration (FDA) has resumed the review process for Herzuma, Celltrion’s biosimilar of Roche’s Herceptin to treat breast cancer with data resubmission for marketing approval completed, the Korean biotech company said on Monday.

The approval procedure will be finalized within six months from the resubmission under the FDA regulations.

Celltrion expects the FDA approval to help it to make further inroads in the global biosimilar market. Celltrion shares were up 2.18 percent to close Monday at 305,000 won ($276.07) in Seoul.

Celltrion made a submission to the FDA to obtain marketing approval for Truxima in April and Herzuma in May, but the FDA halted its review process, ordering supplementary documents from Celltrion based on the findings that a faulty vial lid might lead to contamination at Celltion’s pharmaceutical plant. To facilitate the FDA to resume the review process, Celltrion conducted measures to correct the problem, submitting additional data to the FDA to ensure product integrity of Truxima and Herzuma sequentially.

Celltrion will do its utmost to speed up time-to-market for Herzuma to help many cancer patients in America to access the affordable and effective treatment option, said a company spokesman.

The FDA’s approval, if granted, would bring the number of Celltrion biosimilars to three in the U.S. Remsima available through Pfizer is the only biosimilar from Celltrion for the U.S. market. Truxima and Herzuma would be sold in America through Celltrion’s exclusive distributor Teva.

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