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Celltrion’s Remicade biosimilar nearing U.S. approval

Celltrion is drawing closer to launching its rheumatoid treatment Remsima in the U.S.

The company said Monday that the U.S. Food and Drug Administration is scheduled to hold a committee meeting Feb. 9 (local time) to review and discuss Remsima’s approval in the North American market.

Remsima is a biosimilar replication of Johnson & Johnson’s blockbuster rheumatoid arthritis treatment Remicade.

The entrance to Celltrion's headquarters in Incheon (Yonhap)
The entrance to Celltrion's headquarters in Incheon (Yonhap)

The news prompted Celltrion shares to surge by 17.64 percent from the previous trading day, to close at 116,700 won on the secondary Korean bourse on Monday.

The meeting’s outcome will be significant since a positive recommendation from the committee is typically followed by legal approval by the U.S. FDA.

“Given that Remsima has already been approved in 67 countries including those in Europe, the biosimilar drug is expected to be approved in the U.S. as well,” said NH Investment & Securities analyst Lee Seung-ho.

Celltrion’s new drug is set to emerge as a new game changer in the U.S. arthritis treatment market, which takes up roughly 54.5 percent of Remicade’s entire sales globally.

As Remsima clinically proves its ability to treat additional symptoms including those related to inflammatory diseases, its original replacement rate is slated to further increase, raising Celltrion’s stock price in the process, according to Lee.

By Sohn Ji-young (jys@heraldcorp.com)

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