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# FDA Accepts for Review a Samsung BLA for Remicade Biosimilar
- URL: https://www.fdaweb.com/fda-accepts-for-review-a-samsung-bla-for-remicade-biosimilar/
- Published: 2016-05-23T12:00:00.000Z
- Updated: 2026-09-14T21:04:50.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5135743

FDA has accepted for review a Samsung Bioepis BLA for SB2, a biosimilar candidate referencing Janssen’s Remicade (infliximab) for treating rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and psoriasis. SB2 is the first Samsung Bioepis biosimilar candidate submitted for review in the U.S. If approved, Merck will handle the marketing and distribution of the biosimilar under a 2013 commercialization agreement. Samsung Bioepis says the submission is based on Phase 1 and Phase 3 clinical studies that tested the biosimilarity of SB2 to Remicade. In a 54-week Phase 3 clinical study, SB2 showed comparable safety and equivalent efficacy to Remicade, it says.