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Alvotech Clears A Path For 2024 Ustekinumab In Major Global Markets

Trio Of Licensing Agreements, Including In The EEA, Bolster Firm Amid US Delay

 
• By Dean Rudge

Alvotech has ensured there won’t be any legal hurdles to overcome as it plots launches via commercialization partners for its AVT04 proposed biosimilar to Stelara in major global markets.

Handshake, striking a deal, settlement
• Source: Shutterstock

While the US remains very much the prize for Alvotech in its pursuit of approval and launch for its biosimilar to Stelara (ustekinumab), the Icelandic firm can pat itself on the back after striking a series of settlement agreements with originator Johnson & Johnson that are set to pave the way for launch of the first Stelara biosimilars in major global markets later this year.

Alvotech has reached settlement agreements with J&J in Japan, Canada and in the European Economic Area for its AVT04 biosimilar ustekinumab product. Regulatory approval for AVT04 in these markets has already been granted, the firm pointed out. (Also see "Alvotech Notches Up Another Stelara Biosimilar Approval – In Canada" - Generics Bulletin, 14 November, 2023

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