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Amgen Sued On US Stelara Biosimilar After Providing May 2023 Intent

Janssen Alleges Compound And UC Patents Infringed By ABP 654 Biosimilar

 
• By Dean Rudge

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.

Amgen logo sign hanging on the office building in Rotkreuz, Switzerland
Amgen targets ustekinumab among the next wave • Source: Alamy/Marlon Trottmann

Amgen has told Janssen of its intention to launch its proposed biosimilar to Janssen’s Stelara (ustekinumab) in the US as early as May 2023 – prompting the originator to file suit against the California-based biotech alleging infringement of two of its ustekinumab patents, including its compound patent that issued 17 years ago.

The suit filed by Janssen Biotech in a Delaware district court claims that, on information and belief, Amgen filed its ustekinumab biosimilar, ABP 654,

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