EMA accepts application for AVT04, a proposed biosimilar of Stelara

9 February 2023

Icelandic firm Alvotech (Nasdaq: ALVO) and marketing partner German drugmaker STADA Arzneimittel (SAZ: Xetra) today announced that the European Medicines Agency (EMA) has accepted a Marketing Authorization Application for AVT04, Alvotech’s proposed biosimilar to Stelara (ustekinumab).

The companies anticipate that the EMA could give recommend approving a marketing authorization for AVT04 as soon as in the second half of 2023.

Stelara is marketed by US healthcare giant Johnson & Johnson’s (NYSE: JNJ) subsidiary Janssen Pharmaceutical for a variety of autoimmune diseases including ulcerative colitis and psoriasis. The drug generated global sales of $9.7 billion in full-year 2022, up 6.5% on 2021.

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