Alvotech and Teva progress their Stelara biosimilar

Icelandic firm Alvotech (Nasdaq: ALVO) and the US subsidiary of Israel’s Teva Pharmaceutical Industries (NYSE: TEVA) today announced that the US Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for AVT04, Alvotech’s proposed biosimilar to Johnson & Johnson’s (NYSE: JNJ) Stelara (ustekinumab), which is prescribed to treat a variety of inflammatory conditions. The companies anticipate that the FDA’s review will be completed in second half of 2023.

In 2021, Stelara’s worldwide net sales exceeded $9 billion, and $2.45 billion in the third quarter of 2022, making it one of the highest grossing biologic medicines.

"The progress of AVT04 helps to validate the end-to-end biosimilars development and manufacturing platform that we have built at Alvotech," said Joseph McClellan, chief scientific officer of Alvotech, adding: "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."