Icelandic firm Alvotech (Nasdaq: ALVO) and the US unit of Israel’s Teva Pharmaceutical Industries (NYSE: TEVA) today revealed they have reached a settlement and license agreement with Johnson & Johnson (NYSE: JNJ) concerning AVT04, Alvotech’s proposed biosimilar to Stelara (ustekinumab) in the USA.
The settlement grants a license entry date for AVT04 in the US market no later than February 21, 2025. Stelara, which is indicated for a variety of autoimmune diseases including ulcerative colitis and psoriasis, generated global sales of $9.7 billion in full-year 2022, up 6.5% on 2021.
“We are delighted to have secured a US license date for our second biosimilar candidate in the US and I believe this exemplifies our multi-product approach to biosimilars globally,” said Robert Wessman, chairman and chief executive of Alvotech.
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