Alvotech further demonstrates therapeutic equivalence of its AVT04, a biosimilar to Stelara

25 May 2022

Alvotech Holdings, a privately-held Icelandic biosimilars developer, today announced positive results from a confirmatory clinical study for AVT04, the firms proposed biosimilar to Stelara (ustekinumab).

Alvotech is the second company to announce positive results from a patient study utilizing a biosimilar candidate to Stelara. Teva Pharmaceuticals, a US affiliate of Teva Pharmaceutical Industries (NYSE: TEVA) is the exclusive strategic partner for the commercialization of AVT04 in the USA. German drugmaker STADA Arzneimittel (SAZ: Xetra) is the company’s exclusive strategic partner for AVT04 for the European market.

In 2021, Johnson & Johnson’s (NYSE: JNJ) worldwide net sales of Stelara exceeded $9 billion, making it one of the highest grossing biologic medicines. Ustekinumab is a human IgG1κ monoclonal antibody that binds with specificity to the p40 protein subunit present in both the interleukin (IL)-12 and IL-23 cytokines. Stelara is prescribed to treat a variety of inflammatory conditions including psoriatic arthritis, Crohn’s disease, ulcerative colitis, and plaque psoriasis.

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