Samsung Gets First U.S. Approval

The FDA has approved infliximab-abda (Renflexis), the second biosimilar to Remicade for rheumatoid arthritis and other inflammatory conditions. However, the drug is not yet available in the United States and has not obtained “interchangeable” status from FDA. Pharmacists will not be able to automatically switch out the biosimilar version of Remicade for the brand, as they can with generic drugs.

Samsung Bioepis received approval for Renflexis, the manufacturer’s first drug in the United States. The drug has been available in Europe since last year. Samsung Bioepis is based in Incheon, Republic of Korea, and is a subsidiary of Samsung BioLogics, which is in turn a subsidiary of Samsung Electronics.

Renflexis, which will be marketed and distributed in the United States by Merck, will “be available for launch following a 180-day notice period starting from the time of FDA approval,” Mingi Hyun, a spokesperson for Samsung Bioepis, told Drug Topics.

Related article: Why Remicade biosimilar sales will grow in the U.S.

Europe approved Renflexis (under the brand name Flixabi) in May 2016, and is far ahead of the United States in biosimilar launches and in experience with biosimilar drugs.  

“Flixabi is available in a growing number of European countries,” Hyun said. The manufacturer’s Remicade biosimilar has been approved for marketing in 28 members of the European Union, as well as Norway, Liechtenstein, Iceland, Australia, and the Republic of Korea.

Five biosimilars-including Inflectra, another biosimilar to Remicade-are now approved in the United States, compared to more than 20 such drugs in Europe.

 In the United States, both Inflectra and Renflexis are expected to put a big dent in Johnson & Johnson’s Remicade sales, which reached $4.84 billion in 2016. Hyun said that Samsung Bioepis “is unable to comment on [Renflexis’ price] at this time”, but Inflectra is priced around 15% lower than Remicade.

Related article: How New Biosimilars Will Impact the Market

Renflexis is indicated for reducing signs and symptoms of several types of autoimmune inflammatory conditions, including rheumatoid arthritis, adult and pediatric Crohn’s disease, adult ulcerative colitis, ankylosing spondylitis, and psoriatic arthritis, and for the treatment of adult plaque psoriasis.

 “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 CEO of Samsung Bioepis, in a statement from the company.