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FDA advisory committee recommends approval of Remicade biosimilar

Published on 10/02/16 at 09:08am

An FDA advisory panel yesterday voted overwhelmingly in favour of approving CT-P13- Celltrion’s biosimilar version of Johnson&Johnson’s blockbuster arthritis drug Remicade (infliximab).

The agency’s arthritis advisory panel voted 21-3 in favour of the South Korean company’s copycat version, which it co-markets with Pfizer, having revealed in a briefing document published yesterday that it believed the biosimilar had “no clinically meaningful differences” to the original.

If the agency follows the committee’s advice when making a final decision in April, the biosimilar will go on sale on the US market as Inflectra for all Remicade’s indications, breaking an 18-year monopoly on the drug and likely driving costs down. Remicade sold $4.45 billion in the US in 2015.

Although biosimilar drugs do not offer similarly large percentage discounts to the originals as generic small-molecule drugs, they are often sold as much as 20% below the original products.

HyoungKi Kim, chief executive of Celltrion, welcomed the likelihood of a more cost-effective version of Remicade going on sale, saying: "Given that this would be the first biosimilar monoclonal antibody to be approved in the US, this Advisory Committee meeting is an essential step in increasing acceptance of these critical medicines and increasing access for every patient who needs these treatments. We have experienced the benefits of biosimilars outside of the U.S., including Europe, and are looking forward to advancing our development program with the FDA.

"Our CT-P13 application in the U.S. is the first in an age where biosimilar mAbs are globally recognised as innovative, high quality biologics that are highly similar in both efficacy and safety to their originator products, but are more affordable for patients."

Perhaps unsurprisingly, J&J has raised objections to the panel's decision, with chief biotechnology officer Jay Siegel arguing that Celltrion had not provided sufficient data comparing its biosimilar to Remicade in treating IBS conditions to support its approval in Chron's disease and ulcerative colitis indications. 

Joel Levy

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