KOL Views: FirstWord to assess Celltrion's biosimilar AdCom with Gillian Woollett – FDA practice lead at Avalere

An FDA advisory committee (AdCom) will convene on February 9 to discuss Celltrion's biosimilar Remicade product CT-P13. The meeting should provide much-anticipated insight into the regulator's thinking on highly complex biosimilars. FDA briefing documents – released last week – appear favourable towards Celltrion's application, note analysts at Bernstein. Significantly, they are supportive of extrapolated approval for CT-P13 for each of the seven indications Remicade is approved for.

The 15 member AdCom panel will be asked to vote on four questions pertaining to the biosimilarity of CT-P13 and approvability via extrapolation. However, discussion during the meeting will likely be just as informative for those with a vested interest in the biosimilar market. Although not officially scheduled for discussion, issues such as labelling, switching and interchangeability are likely to be bought up on Monday, notes Bernstein analyst Ronny Gal, just as they were to some extent at an AdCom to discuss Novartis' Zarxio (biosimilar filgrastim) in early 2015.

While the subsequent approval of Zarxio last March marked the FDA's first biosimilar approval, the CT-P13 AdCom should be "significantly more instructive about the approval bar for future biosimilars," notes Gal, given that Remicade is a complex glycosylated monoclonal antibody, which is approved for both rheumatology and gastroenterology indications.

To assess how the AdCom will impact CT-P13, other biosimilar developers and branded manufacturers (facing the threat of biosimilar competition), we are interviewing biosimilar specialist Gillian Woollett – senior vice president at Avalere, who heads up the company's FDA practice – on Wednesday.

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Furthermore, we invite FirstWord Pharma readers to submit their own questions for consideration over the next few hours. Please click here to do so.
We can't guarantee that all questions submitted will be asked due to time constraints, but we will do our utmost to cover the important issues relating to the AdCom and its potential implications on other biosimilar applications.

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