FDA to Review Second Remicade Biosimilar Product

FDA to Review Second Remicade Biosimilar Product

Earlier this week Samsung Bioepis announced that FDA has accepted for review its BLA for SB2, a biosimilar version of Remicade (infliximab).  SB2 is indicated for the treatment of rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and psoriasis, and is the first biosimilar product that the company has submitted.

In reviewing Samsung Bioepis’ BLA, the FDA will assess data from phase I and phase III clinical trials, which compare SB2 to the reference product – Janssen’s Remicade (infliximab).  If approved, the product will be marketed and distributed in the US by Merck.

As it has been less than two months since FDA approved Inflectra, the first Remicade biosimilar, it will be interesting to see what the future holds for Samsung Bioepis’ product.

Do you have a biosimilar or other FDA-regulated product in development?  We can help you develop your 315(k) BLA or any other FDA submission.  To learn more about how we can help you, contact us today.