Newsclip®: [Business] Under Review by FDA: US FDA Accepted Samsung Bioepis’ BLA for SB2 Infliximab Biosimilar | BusinessKorea

"Samsung Bioepis Co., Ltd. announced on May 24 that the U.S. Food and Drug Administration (FDA) has accepted the review of its Biologics License Application (BLA) for SB2, a biosimilar candidate referencing Remicade® (infliximab), for the treatment of rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and psoriasis.",

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