Celltrion said Monday that it has resubmitted the application to obtain marketing approval for Herzuma, a proposed mAb biosimilar to Herceptin (trastuzumab), to the U.S. Food and Drug Administration (FDA).
Celltrion had submitted its abbreviated Biologics License Applications (aBLAs) for Truxima and Herzuma to the FDA in April and May last year, respectively. However, it received complete response letters related to the warning letter issued by the FDA in January 2018, regarding the manufacturing facility.
Celltrion completed the resubmission for the approval of Truxima, a proposed biosimilar to Rituxan, last month. Following FDA regulations, the approval procedure will usually be finalized within six months from the resubmission. Therefore, the company expects the approval for the U.S. market of the two proposed biosimilars within the year.
FDA has also notified Celltrion of its re-inspection schedule regarding regular audit results, and separately from this procedure, it has confirmed the resumption of the review procedure for the two proposed biosimilars upon the resubmission of the aBLAs.
Celltrion and Teva Pharmaceutical entered into an exclusive partnership to commercialize Truxima and Herzuma in the U.S. and Canada in October 2016. As part of the agreement, Teva is responsible for all commercial activities in the U.S. and Canada, pending regulatory approvals for both products. Celltrion is accountable for completing all clinical developments and regulatory activities.