Samsung Bioepis Obtains First Drug Approval in the U.S.

The FDA has approved Samsung Bioepis’ Renflexis (infliximab-abda), a biosimilar referencing Remicade i (infliximab), across all eligible indications. In the U.S., Renflexis is indicated for reducing signs and symptoms in patients with adult and pediatric Crohn’s disease, adult ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis, and for the treatment of adult plaque psoriasis. It is the first Samsung Bioepis product approved for marketing in the U.S..

"Since our company was established five years ago, we have strived day in and day out to realize the promise of biosimilars for patients across the U.S. by offering them treatment options at a lower cost. We hope this regulatory milestone will bring us a step closer to achieving this goal," said Christopher Hansung Ko, president and chief executive officer, Samsung Bioepis. "Through relentless process innovation and an uncompromising commitment to quality, we remain committed to advancing one of the industry's strongest biosimilar pipelines."

Samsung Bioepis’ infliximab biosimilar has also been approved for marketing in 28 EU member states, Norway, Liechtenstein, Iceland, Australia and Korea.

Samsung Bioepis is responsible for the development and manufacture of all immunology and oncology biosimilar candidates in its pipeline, including Renflexis, as well as global clinical trials and regulatory registration in all markets worldwide for these biosimilar candidates.

Renflexis will be marketed and distributed in the U.S. by Merck.