Regulatory Focus™ > News Articles > 10 > FDA Advisory Committee Votes Unanimously to Approve Celltrion’s Rituxan Biosimilar

FDA Advisory Committee Votes Unanimously to Approve Celltrion’s Rituxan Biosimilar

Posted 10 October 2018 | By Zachary Brennan 

FDA Advisory Committee Votes Unanimously to Approve Celltrion’s Rituxan Biosimilar

The US Food and Drug Administration’s (FDA) Oncologic Drugs Advisory Committee (ODAC) voted 16-0 that Celltrion’s and Teva’s CT-P10, a biosimilar to Roche’s Rituxan (rituximab), should be approved for three indications of the reference product.

The vote followed a presentation in which FDA and Celltrion showed that CT-P10 was highly similar and as safe as Rituxan.

The companies said they sought approval for the three proposed non-Hodgkin’s lymphoma indications because of the current patent and exclusivity landscape, a Teva representative said.

William Hancock, chair of bioanalytical chemistry at Northeastern University, noted that while there are some minor differences between the reference product and biosimilar, and no one analytical test will answer all the questions, “I am comfortable with the demonstration of high similarity.”

The thumbs-up from the committee comes as Celltrion in April received a complete response letter from FDA for its June 2017 biologics license application (BLA) for CT-P10, following receipt of a warning letter. The BLA was resubmitted in May.

In the EU, Celltrion’s biosimilar for rituximab was approved by the European Commission in February 2017 and has launched in the UK, Germany, Netherlands, Spain and Korea.

Meeting materials

Categories: Regulatory News

Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe