A recent study evaluated the efficacy, safety, and immunogenicity of switching from reference infliximab (Remicade®, Janssen Biotech), to the biosimilar SB2 (Renflexis®, Samsung Bioepis), in patients with moderate to severe rheumatoid arthritis. This study was an extension of a multinational, multi-center phase III study of SB2, which had reported results from the 54-week main study. In the extension phase starting from week 54, patients previously receiving reference infliximab were randomized to either continue on infliximab or switch to SB2 up to week 70. Patients previously receiving SB2 continued on SB2 up to week 70. The patients were assessed up to week 78.
The authors concluded that efficacy, safety, and immunogenicity profiles were comparable among these three groups up to week 78, with no treatment-emergent issues or clinically relevant immunogenicity after switching from reference infliximab to SB2.
Renflexis® was approved by the FDA on April 21, 2017 for the treatment of Crohn’s disease, pediatric Crohn’s disease, ulcerative colitis (in adult patients), rheumatoid arthritis (in combination with methotrexate), ankylosing spondylitis, psoriatic arthritis and plaque psoriasis.
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