- Samsung Bioepis gets first U.S. FDA note
- Biosimilar will compete with Johnson & Johnson original, version from Pfizer
South Korea's Samsung Bioepis has won a U.S. FDA nod for a biosimilar of Johnson & Johnson's Remicade, marking a first for the company in the U.S. and setting up a path to competition with the world's largest drug company and a similar product made by Pfizer.
Samsung Bioepis, a partnership with Biogen, won U.S. approval for Renflexis, which is a version of infliximab referred to as a biosimilar because it is not an exact chemical copy like a generic drug.
The biosimilar therapy 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.
"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 spoksman Mingi Hyun said in an email.
The FDA nod sets up a complex game of marketing with Merck handling sales of Remicade in Europe, while Samsung has a version called Flixabi approved by the European Medicines Agency last year that is marketed by Biogen in Europe.
But Merck will handle marketing for Renflexis in the U.S. and compete against another biosimilar of Remicade from Pfizer called Inflectra.
The musical chairs on marketing and sales underscore a growing effort to bring more biosimilars to the market in the U.S. akin to generics to bring down prices. That is an aim set forth in the Affordable Health Care Act known as Obamacare, which is the subject of repeal and replace legislation proposed by the Republican-led U.S. Congress and President Donald Trump.
In another aspect on biosimilars, the U.S. Supreme Court could decide by this summer on whether to keep a 180-day waiting period in place before makers of biologic drugs can launch sales after approvals.
--Reuters contributed to this article.