Stelara® Biosimilars: Relief for plaque psoriasis patients

Johnson & Johnson’s (J&J) plaque psoriasis blockbuster drug, Stelara® (Ustekinumab), gained its first approval from U.S. FDA in September 2009. As per J&J’s financial results, the drug has already recorded a sales of close to $2.8 billion by Q2, 2023. Owing to the molecule patent (US6902734) expiry in September 2023, analysts have predicted a sales of $5.4 billion for Stelara® in 2025¹.

Although Stelara®’s molecule patent is expiring in September 2023 in U.S., however, J&J has managed to forestall biosimilar competition until January 2025 by asserting manufacturing patents that claim processes for modifying the animal cell cultures used to manufacture monoclonal antibodies. These patents were filed by Momenta Pharmaceuticals between 2012 and 2015 when it was working to produce biosimilars of Humira, Eylea, and the likes.

With $6.5 billion strategic acquisition of Momenta Pharmaceuticals by J&J in August 2020, (for it’s lead asset Nipocalimab) it has actually acquired manufacturing know-how and intellectual property that Momenta had possessed during its years working on biosimilars and asserted these patents in it’s legal challenges against biosimilar competitors like Amgen, Alvotech, Teva, Formycon, and Fresenius².

Stelara® biosimilars are expected to be in the market as per following schedule:

References:

1. https://www.reuters.com/business/healthcare-pharmaceuticals/stelara-patent-deal-puts-jj-back-path-57-bln-2025-revenue-forecast-2023-06-05/
2. https://www.jnj.com/johnson-johnson-to-acquire-momenta-pharmaceuticals-inc-expanding-janssens-leadership-in-novel-treatments-for-autoimmune-diseases