U.S. closer to approval of ‘biosimilar’ from Korea

Korean biomedicine company Celltrion’s copy of Johnson & Johnson’s best-selling rheumatoid arthritis treatment Remicade received Tuesday a critical recommendation for approval from advisers to the U.S. Food and Drug Administration.

The lower-cost version of the branded drug, which Celltrion calls Remsima, has taken one step closer to winning approval for sales in the United States and becoming the second biosimilar ever approved in the world’s largest pharmaceutical market. It could be approved for the U.S. market in April at the earliest.

The FDA’s independent panel Tuesday voted 21-3 in favor of the Korean replica, which is used to treat rheumatoid arthritis and inflammatory bowel conditions like Crohn’s disease. Prior to the voting, the FDA released a briefing paper Friday that said Remsima appears “highly similar” to Remicade in treating rheumatoid arthritis and a related condition called ankylosing spondylitis. The paper cited “minor differences in clinically inactive components.”

“Clinical tests have proven Remsima has the equal medical effectiveness as the original drug,” said Celltrion in a statement. “The advisory panel’s recommendation should correspond with the U.S. government’s intention to benefit from cutting down medical spending [through the biosimilar product.]”

Remsima is the first biosimilar the Kosdaq-listed Celltrion has developed and commercialized. It is already being marketed in around 70 countries including Canada, China, Japan and in Europe. Sales in Japan began in late 2014 as its government opened the market to new biosimilars while spending heavily on medical support for senior citizens.

U.S. regulators have been more wary of biosimilars than their European counterparts. The first FDA-approved biosilimar is Novartis’ Zarzio, which helps patients in cancer treatment fight infection. The drug won approval last March.

Analysts predict Remsima - should it be approved by the FDA - could be marketed in the United States through Celltrion’s U.S. partner, Pfizer, as early as the second half of this year. Its debut in the United States would be a certain blow to Remicade, which generated $4.45 billion in sales there last year. Remicade saw overseas sales shrink 18.9 percent last year to $1.33 billion from the year before due to the pickup in sales of the Korean biosimilar.

Celltrion is also set to compete in the U.S. market against AbbVie and Amgen’s arthritis treatments Humira and Enbrel.

Biosimilars, according to the FDA, are biological products that are approved based on proof that they are highly similar to other FDA-approved products. The drugs have no clinically meaningful differences in terms of safety or effectiveness from the reference product, but they cost less.

Biosimilars play a similar role in the marketing and sales of biological products, which use living cells, as generics do for chemical-based drugs.

Generics are interchangeable with the original drugs. Biosimilars are not because they use different living cells and could have different reactions in the body.

BY SEO JI-EUN [seo.jieun@joongang.co.kr]