Datapoint: FDA Approves Celltrion’s Humira Biosimilar

The FDA last week approved Celltrion Healthcare’s high-concentration Humira biosimilar, Yuflyma, for eight of Humira’s indications. The company expects to launch the drug, which will be available as both a pre-filled syringe and autoinjector, in July, alongside several other Humira copies from other drugmakers. Celltrion is also seeking interchangeability status from the FDA, and anticipates a decision in the fourth quarter of 2024. The first Humira biosimilar, Amgen’s Amjevita, launched Jan. 31. For the treatment of rheumatoid arthritis, the Amjevita autoinjector currently holds covered or better status for 67% of all insured lives under the pharmacy benefit.

SOURCE: MMIT Analytics, as of 5/26/23

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