Samsung Bioepis said Tuesday it has submitted SB2, a biosimilar drug referencing Johnson & Johnson’s rheumatoid arthritis treatment Remicade, for review by the U.S. Food and Drug Administration.
SB2 is under review for the treatment of rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and psoriasis, the firm said.
Samsung Bioepis' R&D center in Songdo, Incheon (Samsung Bioepis)
It is Samsung Bioepis’ first biosimilar to seek entry into the U.S. market. If approved, the Korean firm’s sales and marketing partner Merck & Co. will handle the drug’s commercialization.
“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 health care expenditures. We hope to do the same in the U.S.,” Samsung Bioepis president and CEO Ko Han-sung said in a statement.
As of now, SB2 is awaiting final approval in Europe. Last month, the European Medicines Agency adopted a “positive opinion” on SB2, to be sold in the region under the name Flixabi.
SB2 was approved for sale in South Korea under the name Renflexis in December 2015, with official sales slated to start next month, according to MSD Korea.
By Sohn Ji-young (
jys@heraldcorp.com)
