Datapoint: FDA Approves Sandoz, Samsung Bioepis’ Stelara Biosimilar

The FDA last week approved Sandoz and Samsung Bioepis’ Stelara biosimilar Pyzchiva (ustekinumab-ttwe) for all of its reference product’s indications, which include severe plaque psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis. The agency granted the biosimilar provisional interchangeability, meaning it can be substituted for Stelara without provider approval in some cases. Pyzchiva joins Amgen’s Wezlana (ustekinumab-auub) and Alvotech and Teva’s Selarsdi (ustekinumab-aekn) as Stelara biosimilars set to launch in the first quarter of 2025, following a settlement and licensing agreement struck with Stelara manufacturer Johnson & Johnson in November 2023. Stelara was first approved in 2009 for the treatment of severe plaque psoriasis, an indication for which it currently holds covered or better status for virtually all insured lives. 37% of insured lives have preferred access to Stelara, largely with utilization management restrictions applied.

SOURCE: MMIT Analytics, as of 7/8/24

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AIS Health Staff

AIS Health Staff

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