FDA Approves 5th Biosimilar Product

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.

Are you in the process of developing or seeking approval of a biosimilar or other FDA-regulated product? We can help ensure a successful interaction with FDA.  To learn more about our services and how we can help you, contact us today.