Samsung unit gets a biosimilar nod in U.S.Samsung Bioepis has taken one step closer to entering the United States, the world’s biggest pharmaceutical market, with its biosimilar of Johnson & Johnson’s rheumatoid arthritis treatment Remicade, also known as Infliximab.
The pharmaceutical arm of Samsung Group said Tuesday the U.S. Food and Drug Administration accepted its application for a review of sales for the drug called SB2, which treats rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and psoriasis.
A biosimilar refers to a close copy of a marketed biotech drug with a less expensive price tag. Remicade, SB2’s original version, last year had global revenues of 9 trillion won ($7.5 billion).
SB2 is the first biosimilar candidate that Samsung Bioepis submitted for review in the U.S. If its sales are approved, marketing and distribution of SB2 will be handled by Merck in accordance with a commercialization agreement signed in 2013.
“We are dedicated to bringing affordable, high-quality biologic medicines to patients across the U.S.,” said Christopher Hansung Ko, president and CEO of Samsung Bioepis. “Already in other countries, our biosimilars have started to play an important role in increasing patient access to high-quality treatment options, while driving down healthcare expenditures. We hope to do the same in the U.S.”
In April, Samsung Bioepis received a positive opinion on SB2 from the European Medicines Agency’s Committee for Medicinal Products for Human Use and is about to receive the green light for sales in Europe.
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