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Samsung Bioepis Aims To Compete On Higher-Strength Humira In US

FDA Accepts sBLA For 100mg/ml Citrate-Free Version Of Hadlima Biosimilar

Executive Summary

Samsung Bioepis and Organon have revealed plans to compete with higher-concentration formulations of adalimumab in the US, after the FDA accepted for review an sBLA for a citrate-free 100mg/ml version of the SB5 Hadlima biosimilar that is already approved in a 50mg/ml formulation.

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