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The U.S. Food and Drug Administration has cleared the way for sales of a biosimilar
drug made by a Korean company... for Johnson & Johnson's top selling anti-inflammatory
drug Remicade. This is only the second time the FDA has given
the green light to a biotech drug for the U.S. market.
Kim Min-ji reports. Korean bio-pharmaceutical firm Celltrion's
biosimilar drug Remsima... is set to hit the U.S. market.
The U.S. Food and Drug Administration gave the final approval on Wednesday to allow sales
of the cheaper replica of Johnson & Johnson's top selling drug Remicade.
The anti-inflammatory drug is used to treat patients with a number of serious conditions,...
including Crohn's disease and rheumatoid arthritis. Biosimilars are biologic medical products
with similar properties to ones that have already been approved.
What's significant is that Remsima is the world's first Remicade biosimilar to gain
a footing in the U.S.,... which makes up about a half of the global replica market.
It's expected that Celltrion will be able to garner annual sales of up to 1-point-7
billion dollars in the U.S. market. Remicade, which was first approved in 1998,...
posted sales of about four and a half billion dollars last year.
Many in Korea are hoping this will pave the way for faster development of other biosimilars
made by Korean firms. Currently, clinical testing is underway for
12 such products.
Celltrion first got the thumbs up from the Korean Ministry of Food and Drug Safety in
2012... and the European Medicines Agency in 2013.
It's currently being sold in some 70 countries worldwide.
Pfizer will be in charge of marketing and sales of the product in the U.S.,... under
the name Inflectra.,... and sales are expected to start in the third quarter of this year.
Kim Min-ji, Arirang News.