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Alvotech announces expected global market entry dates for AVT 04 biosimilar to Stelara (ustekinumab)

Written by | 1 Mar 2024

Alvotech announced that it has reached settlement agreements with Johnson & Johnson in Japan, Canada and in the European Economic Area (EEA) for AVT 04, a biosimilar to… read more.

FDA accepts BLA for Ustekinumab biosimilar – Alvotech

Written by | 21 Feb 2024

The FDA has accepted a biologics license application (BLA) for Alvotech’s ustekinumab biosimilar candidate (AVT 04) referencing Stelara, which will be used to treat several autoimmune disorders. Alvotech… read more.

Complete Response Letter for AVT 02 biosimilar candidate for Humira – Alvotech

Written by | 8 Jul 2023

Alvotech announced that the FDA has issued a complete response letter (CRL) for Alvotech’s second Biologics License Application (BLA) for AVT 02, a high-concentration biosimilar candidate for Humira… read more.

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