Datapoint: FDA Approves Alvotech and Teva’s Stelara Biosimilar

The FDA last week approved Alvotech and Teva’s Stelara biosimilar Selarsdi (ustekinumab-aekn) for the treatment of moderate to severe plaque psoriasis and active psoriatic arthritis in adults and pediatric patients 6 years and older. The drugmakers said they plan to launch the drug, the second FDA-approved Stelara biosimilar behind Amgen’s Wezlana, in early 2025. For the treatment of psoriasis, Stelara currently holds covered or better status for 73% of all insured lives under the medical benefit. The biologic brought Johnson and Johnson $10.86 billion in global sales in 2023.

SOURCE: MMIT Analytics, as of 4/19/24 and Evaluate Pharma

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