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S. Korean firm wins FDA approval for biosimilar

All News 10:51 April 06, 2016

SEOUL, April 6 (Yonhap) -- Celltrion Inc., a South Korean bio-pharmaceutical firm, said Wednesday it has won approval from the U.S. Food and Drug Administration (FDA) to sell its biosimilar in the United States, a move which will speed up the country's export of drug products.

The biosimilar, dubbed Remsima, will go on sale during the third quarter this year under the name Inflectra, the company said. It is the second biosimilar ever to be approved by the FDA.

Biosimilars are defined by the FDA as products that are "highly similar to an already-approved biological product," that has "no clinically meaningful differences in terms of safety and effectiveness from the reference product."

Remsima is a biosimilar to Janssen Biotech, Inc.'s Remicade, effective for various diseases from rheumatoid arthritis to Crohn's disease.

Celltrion said Remsima is expected to rack up annual sales of 2 trillion won (US$1.72 billion) in the U.S. The annual sales of Remicade hover around $4.5 billion.

While the U.S. had been reluctant to bolster its biosimilar market to protect its domestic pharmaceutical industry, the country recently changed its stance to ease burdens on medical expenditures.


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