Protecting its megablockbuster, Janssen challenges Amgen's Stelara biosimilar ahead of planned 2023 launch
Johnson & Johnson unit Janssen on Wednesday sued Amgen over the company’s proposed biosimilar to its megablockbuster Stelara (ustekinumab), after Amgen said it was ready to launch next May or as soon as the FDA signs off on it.
If Amgen carries through with that plan, Janssen told the Delaware district court that the Thousand Oaks, CA-based company will infringe on at least two Janssen patents.
The suit follows Amgen’s announcement in April that preliminary results from a Phase III study evaluating the efficacy and safety of its ustekinumab biosimilar, known as ABP 654, met its primary efficacy endpoint in adult patients with moderate-to-severe plaque psoriasis, demonstrating no clinically meaningful differences between ABP 654 and Stelara.
Earlier this month, Amgen also said that the Phase III data were submitted to the FDA to support its biosimilar application, and Janssen says Amgen is also seeking an interchangeability tag, which could potentially make it more competitive if other biosimilars to Stelara enter the market.
Janssen says that the FDA submission constitutes an infringement on its Stelara patents, even as the J&J subsidiary contends that Amgen refused to disclose when it filed its application, whether the FDA has accepted it, whether Amgen will participate in the so-called “patent dance,” or whether the law’s deadline by which Amgen must provide Janssen with a copy of its application has passed.
“Amgen’s stated intention to launch its ABP 654 biosimilar product as soon as possible presents a controversy of sufficient immediacy to support declaratory judgment of patent infringement,” the suit says.
First approved in 2009, Stelara hauled in more than $11 billion in sales in 2020 and 2021, and is now prescribed as a treatment for plaque psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis.
Other potential Stelara biosimilar competitors may come from Iceland-based Alvotech, Germany’s Formycon, China-based Bio-Thera Solutions, as well as the Korea-based companies Samsung Bioepis, Celltrion, and Dong-A ST. The composition of matter patent for Stelara expires next year.