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Delays for Celltrion’s Yuflyma® (adalimumab) biosimilar in US

Feb 24, 2023

The Korea Biomedical Review has reported that Celltrion has explained to shareholders the delay in obtaining US approval for its Humira® adalimumab biosimilar Yuflyma®. Despite obtaining EMA approval in December 2020, Celltrion confirmed that FDA took issue with Celltrion’s overseas and end-product manufacturing plants. Celltrion has rectified the problems and the FDA will complete a final review by May 2023. We have previously reported on Yuflyma®’s progress and approvals including its EU approval in December 2020, in CA on 24 December 2021 and in AU on 28 February 2022.   Celltrion is licensed to supply Yuflyma® in the US from July 2023 pursuant to its settlement with AbbVie.