Celltrion Receives FDA Complete Response Letter for Biosimilars of Two Roche Blockbuster Drugs

Celltrion, an Incheon, South Korea-based life-sciences company, has received Complete Response Letters (CRLs) from the US Food and Drug Administration (FDA) regarding the company’s biologics license applications (BLA) for proposed biosimilars of rituximab, which references Roche’s Rituxan, and trastuzumab, which references Roche’s Herceptin. Rituxan and Herceptin respectively had 2017 global  sales of CHF 7.3 billion ($7.8 billion) and CHF 7.01 billion ($7.5 billion).

The FDA issued a Warning Letter to Celltrion in January 2018 for violations of good manufacturing practices for finished pharmaceuticals. The Warning Letter was in response to an inspection the FDA carried out from May 22 to June 2, 2017 at the company’s drug-manufacturing facility in Incheon, South Korea.

“Celltrion is making progress addressing the concerns raised by the FDA in a Warning Letter issued in January and is committed to working with the agency to fully resolve all outstanding issues with the highest priority and urgency,” said Celltrion in on April 6, 2018 company statement.

Celltrion says that it expects resubmission will be in-place relatively soon after which the company says it expects approvals in six months after resubmission within regulatory timelines.

Source: Celltrion


Leave a Reply

Your email address will not be published. Required fields are marked *