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Biosimilars are copies of biotech drugs... closely watched by investors for their potential
to take business away from companies making the original, expensive product.
An anti-inflammatory biosimilar drug made by a Korean firm has been given the green
light by the U.S. FDA... making it only the second replica drug to be approved for sales
in the U.S. market. Kim Min-ji has more on the entry in a fledgling
U.S. market for lower-cost copies of pricey biotechnology drugs.
Korean bio-pharmaceutical firm Celltrion's biosimilar drug, Inflectra, is set to hit
the U.S. market. The U.S. Food and Drug Administration gave
its 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 already on
the market.
What's significant is that Inflectra is the world's first Remicade biosimilar to gain
a footing in the U.S.,... which makes up about 50 percent of the global replica market.
Celltrion expects to garner annual sales of up to 1-point-7 billion dollars in the U.S.
Not only is the replica similar in effectiveness and safety in comparison to Remicade,... it's
also projected to be about 20 to 30 percent cheaper than the original.
In fact, after sales began in Europe in 2014,... Johnson & Johnson saw its overseas sales plunge.
Last year,... sales fell almost 19 percent on-year to just over 1-point-3 billion dollars.
And with the prescription rate of replica products at 88 percent in the U.S.,... it
could deal further blow to sales of the original.
Many in Korea are also hoping the approval of Inflectra will pave the way for faster
development of other biosimilars produced by Korean firms.
Currently, clinical testing is underway for 12 such products.
Celltrion first received the thumbs up for Inflectra,... or Remsima as its known in Korea,...
from the Korean Ministry of Food and Drug Safety in 2012... and the European Medicines
Agency in 2013. Pfizer, Celltrion's partner on Inflectra,
will be in charge of marketing and sales of the drug, expected to kick off in the third
quarter. Kim Min-ji, Arirang News.