US FDA postpones Celltrion's Remicade biosimilar review meeting

By Gareth Macdonald contact

- Last updated on GMT

US FDA delays Celltrion meeting
US FDA delays Celltrion meeting

Related tags: Monoclonal antibodies, Food and drug administration

The US FDA has delayed an advisory committee review of Celltrion's Remicade (infliximab) biosimilar after asking the South Korean drugmaker for more information.

The US Food and Drug Administration (FDA) postponed the March 17 meeting of its Arthritis Advisory Committee, explaining that the review of Celltrion's Remicade biosimilar - CT-P13 - would be rescheduled.

The agency said​ the postponement was “due to information requests pending with the sponsor of the application​” but did not provide details.

Celltrion declined to tell BioPharma-Reporter.com what information the US regulator had requested and stressed instead that “it is not unprecedented for the FDA to change the date of an Advisory Committee meeting.”

Early days

To date there has only been one advisory committee meeting​ about a biosimilar, so it is too early to say if the delay is significant.

Patent lawyer Stacie Ropka from Axinn told us “You cannot read too much into it. FDA could simply be looking for additional information." 

"And, of course it is particularly difficult to know if it is of particular significance in the biosimilar context. This was only the second application filed with FDA and was the first biosimilar application for a monoclonal antibody​.” 

And meeting dates for originator biopharmaceuticals have been changed in the past. Another industry expert we asked told us "it’s not unusual for meetings to be postponed​."

He added that: "The analytical data in Celltrion EMA submission​ was very detailed and since this is the first monoclonal antibody in the US it may take longer for the FDA to review, particularly as this will set a precedent for the future molecules considered."

The South Korean firm told us it will work closely with the FDA in its review of biosimilar infliximab and added that the rescheduled meeting will be announced in the Federal Register.

Biosimilar roll out

The drug CT-P13 – which is sold as Remsima elsewhere by Celltrion and as Inflectra by licensee Hospira – was filed for review in the US last August​.

Celltrion submitted the Biologics License Application (BLA) and – if CT-P13 is approved – Hospira will sell the drug in the US.

News of the meeting delay comes at the end of a month​ of Remsima lanuches by Celltrion's partner Mundipharma, which sells the drug in Germany, Italy, the UK, the Netherlands, Belgium and Luxembourg.

Hospira will sell the drug in Austria, Denmark, France, Germany, Greece, Italy, Luxembourg, the Netherlands, Spain and Sweden as Inflectra.

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