FDA clears second Remicade biosimilar

In what is expected to produce hefty savings for rheumatoid arthritis (RA) patients and the healthcare system, FDA approved the second biosimilar to Remicade (Johnson & Johnson).

Samsung Bioepis Co.’s infliximab-abda (Renflexis) was just approved, after FDA approved the biosimilar infliximab-dyyb (Inflectra, Pfizer and Celltrion) last year. The new drug will be marketed and distributed in the United States by Merck.

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Renflexis, the first drug for Samsung Bioepsis in the United States, is indicated for reducing signs and symptoms in patients with RA, 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 US 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.

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The new biosimilar is also expected to impact Johnson & Johnson’s U.S. Remicade sales, which reached $4.84 billion in 2016.

Renflexis has also been approved in 28 European Union (EU) member states, Norway, Liechtenstein, Iceland, Australia and Korea. 

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