Celltrion wins FDA approval for biosimilar [2016/04/20 11:25]

Celltrion, a South Korean biopharmaceutical firm, said on April 6 that it had won approval from the U.S. Food and Drug Administration (U.S. 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 U.S. FDA.

“The approval signifies recognition of Korea’s biopharma technology by the world’s most prestigious health regulator, setting a milestone for Korea’s biopharma sector,” Celltrion’s CEO Kim Hyoung-ki told reporters in Seoul.

Biosimilars are defined by the U.S. 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’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 ($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 the burden of medical expenditures.
출처: 주니어 영자신문 주니어헤럴드(junior.heraldm.com)