J&J has struck a deal that would allow Alvotech and Teva a license in the U.S. to market their planned biosimilar version of Stelara, known as AVT04. The firms said that the settlement gives the biosimilar manufacturer permission to debut their version around February 21, 2025.
As a result of this settlement, the product replicating Stelara has a better chance of entering the country without any problems arising from the infringement of its patent at the start of 2025.
The Stelara biosimilar pact follows closely on the heels of another one that J&J recently negotiated with Amgen. That agreement grants Amgen a license to market its imitation no later than January 1, 2025.
Similar to Amgen, Alvotech, and Teva have not received approval from the FDA for their product AVT04. The two stated in January that their application had been approved by the FDA and that a decision was expected to be made within the second half of this year. It is anticipated that a decision about Amgen’s version will be made before the end of the third quarter.
J&J’s Stance on Biosimilar Entry Dates
- J&J places a high priority on determining the entry dates for the biosimilars.
- Stelara was J&J’s top-selling medicine in 2022, with sales of $9.7 billion.
- It also accounted for 10% of the pharma giant’s total revenue base, making it the company’s single most profitable product.
- The U.S. contributed around $6 billion to the total haul.
Crohn’s disease, psoriatic arthritis, psoriasis, and ulcerative colitis are only a few of the inflammatory disorders that have been authorized for treatment with the IL-12/23 inhibitor. The composition of matter patent for the medication in the U.S. will run out in September.
Samsung Bioepis, Celltrion, Biocon, and cooperation between Bio-Thera and Hikma are among the other enterprises working on Stelara biosimilars.
Teva and Alvotech formed a strategic collaboration in 2020 to collaborate on the development of five biosimilar candidates in the U.S. AVT04 was one of those prospects. Teva is in charge of the commercialization of the product, while Alvotech handles the development, regulatory, and manufacturing processes.
However, Alvotech has not exactly established a reputation as the most dependable drug manufacturer. The Icelandic company said in April that it got a second comprehensive response letter from the FDA about its request for AVT02, a high-concentration biosimilar of AbbVie’s Humira.
After a second examination of Alvotech’s Icelandic site in Reykjavik revealed some problems, the agency rejected the firm. According to the company, the application is still being evaluated as of June 28.
Alvotech’s collaboration with Teva also includes the biosimilars AVT05 (a copy of J&J’s anti-TNF agent Simponi), AVT06 (a replica of Regeneron’s eye drug Eylea), and AVT16 (a copy of an unidentified immunology treatment).
The new Teva CEO, Richard Francis, has prioritized biosimilars as part of the firm’s strategy to revive its growth. Teva has identified seven biosimilar prospects in late-stage research, including the neurological medications Austedo and Uzedy, as potential revenue generators in the near future.
