Celltrion Progresses Biosimilars of Roche’s Rituxan and Herceptin

Celltrion, an Incheon, South Korea-based life-sciences company, has resubmitted a biologics license application (BLA) to the US Food and Drug Administration (FDA) for approval of its biosimilar candidate that references Roche’s Rituxan (rituximab), a drug to treat certain cancers and autoimmune diseases. It also plans to resubmit its BLA to the FDA for approval of a second biosimilar, which references Roche’s Herceptin (trastuzumab), a cancer drug. Rituxan had 2017 global sales of CHF 7.3 billion ($7.8 billion), and Herceptin had 2017 global sales of CHF 7.01 billion ($7.5 billion).

Celltrion submitted the original BLAs for the biosimilars 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 said that it has made progress in addressing the issues raised in the Warning Letter. Celltrion said that the FDA has recently notified Celltrion of its re-inspection schedule. Separately, Celltrion says that the FDA has confirmed that the approval procedure for the two proposed biosimilars will resume upon resubmission. In accordance with FDA regulations, the approval procedure will usually be finalized within six months from resubmission.

Source: Celltrion

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