Amgen Sued On US Stelara Biosimilar After Providing May 2023 Intent
Janssen Alleges Compound And UC Patents Infringed By ABP 654 Biosimilar
With Janssen’s Stelara set to lose its exclusivity in September 2023, the originator is looking to ward off potential biosimilar competition from Amgen by suing the firm for patent infringement in a US district court.
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Years before Humira rivals hit the US market in 2023, a series of litigation settlements between biosimilar adalimumab developers and originator AbbVie provided a roadmap for a succession of date-certain launches this year. Now, similar settlements over Stelara between J&J and ustekinumab developers are starting to fall into place for 2025.
Teva and Alvotech have struck a deal with Stelara originator Johnson & Johnson to secure a 21 February 2025 launch date for their AVT04 ustekinumab biosimilar in the US – just over seven weeks after rival Amgen is able to enter the market.
Samsung Bioepis has reported positive Phase I data for its SB17 ustekinumab candidate, a proposed biosimilar to Stelara.