Like its Korean counterpart Celltrion Inc. before it, Samsung Bioepis Co. Ltd. is banking on extrapolation of clinical data in arthritic indications to support approval of SB2, its proposed biosimilar to Remicade, for treatment of inflammatory bowel diseases as well.
Remicade Biosimilars: Samsung Looks To Follow Celltrion's Footsteps
351(k) application relies on data extrapolation from Phase III trial in rheumatoid arthritis to support approval across infliximab's indications, including inflammatory bowel disease.
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