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FDA accepts sBLA for citrate-free, high-concentration biosimilar adalimumab candidate

Jan 5, 2022

Samsung Bioepis and Organon announced that the FDA has accepted for review the supplemental Biologics License Application for a citrate-free, high-concentration formulation of SB5 (biosimilar adalimumab).  Organon expects to launch this product in the US on or after 1 July 2023, in accordance with a licensing agreement with AbbVie.

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