Celltrion Resubmits to FDA Its Proposed Biosimilar to Roche’s Herceptin

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The company has resubmitted a biologics license application to FDA for its proposed biosimilar to Roche’s Herceptin.

On June 18, 2018, Celltrion announced that it has resubmitted a biologics license application (BLA) to FDA for its proposed biosimilar to Roche’s Herceptin (trastuzumab), a biologic for treating breast, stomach, and esophageal cancer. Herceptin is one of Roche’s top-selling products with 2017 global sales of CHF 7.01 billion ($7.5 billion).

Celltrion originally submitted BLAs for its biosimilar candidates to Roche’s Rituxan/MabThera (rituximab) and trastuzumab to FDA in April and May 2017, respectively. Celltrion received complete response letters (CRLs) from FDA related to the warning letter issued by the agency in January 2018 after an inspection carried out from May 22 to June 2, 2017 at Celltrion’s drug manufacturing facility in Incheon, South Korea. The letter raised issues related to certain manufacturing process at the facility.

According to the warning letter, Celltrion failed to establish and follow appropriate written procedures designed to prevent microbiological contamination and ensure product sterility, including validation of all aseptic and sterilization processes. The warning letter also stated that the company failed to thoroughly investigate unexplained discrepancies/failures of batches and to establish an adequate system for monitoring environmental conditions in aseptic processing areas.

According to Celltrion, the company resubmitted approval for its proposed rituximab biosimilar in May 2018. The approval procedure is expected to be finalized within six months from the resubmission and Celltrion expects approval for the United States market of the two proposed biosimilars within the 2018 calendar year.   


FDA has notified the company of its re-inspection schedule regarding regular audit results. Separately from this procedure, FDA has also confirmed the resumption of the review procedure for the two proposed biosimilars upon the resubmission of the BLAs.

Celltrion and Teva Pharmaceutical entered into an exclusive partnership to commercialize their trastuzumab and rituximab biosimilars in the US and Canada in October 2016. As part of the agreement, Teva is responsible for all commercial activities in the US and Canada, pending regulatory approvals for both products. Celltrion is responsible for completing all clinical developments and regulatory activities.

Source: Celltrion