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FDA accepts Organon’/Samsung Bioepis' sBLA for Humira biosimilar candidate

Headquarters of US Food and Drug Administration (FDA)

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  • Samsung Bioepis and Organon (NYSE:OGN) announce that the FDA has accepted for review the supplemental Biologics License Application (sBLA) for a citrate-free, high-concentration (100 mg/mL) formulation of SB5 (adalimumab-bwwd), a biosimilar candidate referencing AbbVie's HUMIRA (adalimumab).

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