FDA nod for interchangeability of Selarsdi with Stelara

5 May 2025

Teva Pharmaceutical Industries’ (NYSE and TASE: TEVA) US subsidiary and Iceland-based Alvotech (Nasdaq: ALVO) today announced that the US Food and Drug Administration (FDA) has approved Selarsdi (ustekinumab-aekn) injection as interchangeable with the reference biologic Stelara (ustekinumab).

Marketed by Johnson & Johnson ((NYSE: JNJ), Stelara generated global sales of $1.63 billion in the first quarter of this year, down 34%, already impacted by biosimilar competition.

As of April 30, 2025, Selarsdi is available and interchangeable in all presentations matching the reference product, including the treatment of adults and pediatric psoriatic arthritis and plaque psoriasis, as well as Crohn’s disease, and ulcerative colitis.

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