FDA Approves 5th Biosimilar Product
On Friday, April 21st, Reneflexis® (SB2, infliximab – abda) was approved by the FDA. Reneflexis is manufactured by Samsung Bioeipis, and is a biosimilar product to Janssen’s Remicade® (infliximab). Reneflexis is the fifth biosimilar product, and the second infliximab biosimilar approved by the FDA.
The FDA approved Reneflexis for all eligible indications, which include the following:
- Reducing the signs and symptoms in patients with:
- Adult & pediatric Crohn’s disease
- Adult ulcerative colitis
- Adult rheumatoid arthritis
- Adult ankylosing spondylitis
- Adult psoriatic arthritis
- Treatment of adult plaque psoriasis
The FDA accepted the product for review in May 2016, and this is the first Samsung Bioepis product that has been approved by the Agency for sale in the US.
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