Datapoint: FDA Approves High-Concentration Humira Biosimilar

The FDA last week approved Samsung Bioepis Co., Ltd. and Organon & Co.’s high-concentration, citrate-free Humira biosimilar, Hadlima, across seven of Humira’s indications. The injectable was previously approved in its low-concentration formulation. Hadlima, like all other approved Humira biosimilars, cannot launch earlier than July 1, 2023. Under the pharmacy benefit, Humira holds covered or better status for 98% of all insured lives. About 13% of lives have preferred access to Humira, growing to 64% with utilization management restrictions applied.

SOURCE: MMIT Analytics, as of 8/22/22

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AIS Health Staff

AIS Health Staff

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