July 18, 2019

FDA takes final step for approving Celltrion’s Rituxan biosimilar

PUBLISHED : September 12, 2018 - 15:55

UPDATED : September 12, 2018 - 17:30

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[THE INVESTOR] The US Food and Drug Administration will hold an advisory committee meeting next month to gather opinions from experts on Celltrion's CT-P10, a biosimilar referencing Roche’s blood cancer therapy Rituxan before taking a final decision to allow sales.

According to a Federal Register notice posted by the FDA, the Oncologic Drugs Advisory Committee will provide advice and recommendations to the health agency on Oct. 10 regarding biologics license application for CT-P10, also known as Truxima, developed by Celltrion. 

The FDA holds such public advisory committee meetings before it approves first biosimilar versions.

A similar meeting was held for Celltrion’s Inflectra, the first copycat of Johnson & Johnson’s Remicade to make it to the US market, a Celltrion official told The Investor.

Truxima has been under FDA review since June following the resubmission of its application for marketing approval in May after its first attempt failed due to production facility and manufacturing process issues.

“Celltrion is seeking to fulfill the intrinsic value of biosimilar by providing affordable treatment options to cancer patients in the US as we do in other countries including Europe,” the company said in a statement.

Since it was approved in the EU in February last year, Truxima has been expanding its prescription rate. It gobbled up 27 percent of the original drug’s market share in the first quarter.

Meanwhile, another biosimilar Herzuma, its version of Roche’s breast cancer treatment Herceptin, is also awaiting FDA approval. The US health authority resumed review of Herzuma in June after a setback for the same reason as Truxima. An advisory meeting is not planned for Herzuma because Mylan’s copycat called Ogivri was the first approved drug for the US market in 2017.

At the time of resubmission application, the Korean biopharmaceutical firm had expected that the two biosimilar candidates will be approved before the year ends.

By Park Han-na (

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