Samsung Bioepis a partnership with Biogen, gained the first approval for the U.S. market from FDA on a biosimilar of Johnson & Johnson’s Remicade.
The drug approved, Renflexis, is a version of infliximab and 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.
This approval also open the path to competition with the world’s largest drug company and a similar product made by Pfizer: Inflectra
It is now starting also a complex game of marketing with Merck handling sales of Johnson & Johnson’s Remicade in Europe, while Samsung versios, Flixabi is marketed by Biogen in Europe. In U.S Merck will handle marketing for Renflexis. competing against the Pfizer’s Inflectra.
“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 United States 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 & CEO of 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.”