April 24, 2024

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[THE INVESTOR] Celltrion said on July 18 it has made a resubmission to the US Food and Drug Administration to receive marketing approval for CT-P6, a proposed biosimilar to Roche’s breast cancer treatment Herceptin.

This is the second attempt by the Incheon-based biopharmaceutical firm to bring CT-P6, also known as Herzuma, to the US market as the FDA had turned down its Biologics License Applications for the drug and another biosmilar Truxima in January, due to production facility and manufacturing process issues. 

Celltrion hopes to get FDA’s nod for Herzuma and Truxima by end-2018 as the review procedure typically takes about six months after resubmission. The second application for Truxima was handed in last month.

This year alone, the FDA has rejected three Herceptin biosimilar candidates developed by Amgen, Celltrion and Pfizer.

If Celltrion clears the final regulatory hurdle within the expected timeframe, Herzuma will become the second Herceptin biosmilar to be approved by the FDA after Mylan and Biocon’s version Ogivri. Amgen and Pfizer are yet to make their resubmission.

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

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