ODAC to Discuss Celltrion's CT-P10 in October 2018

Korean drug maker Celltrion says that the FDA’s Oncologic Drugs Advisory Committee (ODAC) will convene to discuss the Biologics License Application (BLA) for CT-P10, a proposed biosimilar rituximab, on October 10, 2018. CT-P10 is already authorized in the European Union, where it was approved under the trade names Rituzena, Ritemvia, Truxima, and Blitzima.
The Center for Biosimilars Staff
September 12, 2018
Korean drug maker Celltrion says that the FDA’s Oncologic Drugs Advisory Committee (ODAC) will convene to discuss the Biologics License Application (BLA) for CT-P10, a proposed biosimilar rituximab, on October 10, 2018. CT-P10 is already authorized in the European Union, where it was approved under the trade names Rituzena, Ritemvia, Truxima, and Blitzima.

“We are fully committed to preparing for this advisory committee meeting and look forward to the discussion about CT-P10,” Woosung Kee, CEO of Celltrion, said in a statement announcing the committee’s meeting. “The development of biosimilars is of great importance in the field of oncology, and has the potential to enrich our therapeutic arsenal and to increase accessibility to therapies for patients at an affordable price.”

Click to read more about CT-P10. 

Announcement of the ODAC meeting is a step forward for the drug maker in the United States. Celltrion received a Complete Response Letter (CRL) from the FDA with respect to its rituximab BLA—along with a CRL related to the BLA for a proposed trastuzumab biosimilar—in April of this year. At the time, the company said that the FDA had requested additional information about both products. It also sought to reassure investors that it was taking steps to address concerns that led the FDA to issue a Form 483 to Celltrion over its manufacturing practices.

The last occasion on which the ODAC convened for a discussion of anticancer biosimilars was July 2017, when the committee discussed Amgen’s bevacizumab product, later approved as Mvasi, and Biocon’s trastuzumab product, later approved as Ogivri. On that occasion, the committee voted unanimously in favor of approval of both products, and for the extrapolation of all indications of the originator products.

The discussion of extrapolation is likely to be of particular interest in the case of CT-P10; rituximab is used to treat both malignant and non-malignant indications. While the biosimilar has been studied in patients with follicular lymphoma and the ODAC will review the BLA for the product, the biosimilar has also been studied in a phase 3 trial in patients with rheumatoid arthritis (RA). The study in RA revealed that CT-P10 were equivalent in terms of efficacy and had similar pharmacokinetic, immunogenicity, and safety profiles up to week 24.

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