Alvotech’s Ustekinumab Biosimilar Application With the FDA: Decision Expected Before End of Year

Alvotech has emerged first out of the blocks in the race to bring a Stelara® biosimilar to the US market. The company announced that the FDA accepted its 351(k) application for AVT02 on January 6, which should position it for a decision in the fourth quarter of this year.

Alvotech had announced a successful conclusion to its late-stage confirmatory trial of AVT02 in May 2022, finding that it was noninferior to the reference product in the treatment of patients with plaque psoriasis. Should the drug be approved, it will be marketed by Teva in the US.

ATV02 is also the first interleukin (an interleukin 12/23 biologic) to be submitted for FDA approval. Others, like secukinumab, will follow in a few years. The principal patent for Stelara is set to expire in September 2023.

The ustekinumab biosimilar competition should be fierce, with up to six biosimilar makers in late-stage trials. Amgen is expecting completion of its multiswitch study in March 2023 for a potential interchangeability designation. The assumption is that Celltrion, Samsung Bioepis, Formycon, and Bio-Thera may enter the fray as well.

In 2022, US revenues for Stelara were approximately $6.5 billion (roughly an 8% increase over 2021), based on results up through the third quarter of last year. The principal patent on Stelara expires in September 2023.

Joseph McClellan, Alvotech’s Chief Scientific Officer, stated, “The progress of AVT04 helps to validate the end-to-end biosimilars development and manufacturing platform that we have built at Alvotech.” He continued, “Our approach is multi-product, and we look forward to broadening our portfolio as we continue to focus on expanding access to affordable biologic medicines.”

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