Celltrion Resubmits to FDA Proposed Biosimilar of Roche’s Blockbuster Drug Herceptin

Celltrion, an Incheon, South Korea-based biopharmaceutical company of biosimilars and innovator drugs, has resubmitted a biologics license application (BLA) to the US Food and Drug Administration (FDA) for its biosimilar candidate that references Roche’s Herceptin (trastuzumab), a cancer drug. Herceptin had 2017 global sales of CHF 7.01 billion ($7.5 billion).

Celltrion submitted the original BLAs for its biosimilar to Roche’s Herceptin and to a second biosimilar candidate that referenced Roche’s Rituxan (rituximab), a drug to treat certain cancers and autoimmune diseases in April and May of 2017, but it later received in April 2018 a Complete Response Letter (CRL) from the FDA over manufacturing issues. The CRL followed the issuance of a Warning Letter by the FDA to Celltrion in January 2018 for violations of good manufacturing practices for finished pharmaceuticals. The Warning Letter was in response to an FDA inspection carried out from May 22 to June 2, 2017 at the company’s drug-manufacturing facility in Incheon.

Celltrion had completed the resubmission for the approval of its proposed biosimilar to Rituxan last month (May 2018). In accordance with FDA regulations, the approval procedure will be usually finalized within six months from the resubmission, so Celltrion said it expects the approval for the US market of the two proposed biosimilars within this calendar year.  

The FDA has 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 BLAs, according to information from Celltrion.

Celltrion and Teva Pharmaceutical Industries formed an exclusive partnership to commercialize the two biosimilars in the US and Canada in October 2016. Under 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

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