Alvotech and Teva Settle with Johnson & Johnson for Stelara Biosimilar AVT04 in the US

- Johnson & Johnson has reached a settlement agreement with Alvotech and Teva, granting them a license for their proposed biosimilar of Stelara, named AVT04, in the United States.
- The settlement allows Alvotech and Teva to launch their biosimilar no later than February 21, 2025.
- This settlement follows a similar agreement made between J&J and Amgen, allowing Amgen's Stelara biosimilar to launch no later than January 1, 2025.
- Stelara, J&J's top-selling drug with $9.7 billion sales in 2022, has a U.S. composition of matter patent that will expire in September.
- Alvotech and Teva have not yet received FDA approval for AVT04, with the FDA's decision targeted for the second half of 2024.
- Other companies developing Stelara biosimilars include Samsung Bioepis, Celltrion, Biocon, and a partnership between Bio-Thera and Hikma.
- Teva is responsible for the commercialization of AVT04, as part of a strategic partnership with Alvotech that covers five biosimilar candidates in the U.S.
- Alvotech, who handles development, regulatory, and manufacturing, has experienced some challenges, such as a second complete response letter from the FDA regarding its AVT02, a Humira biosimilar, due to certain deficiencies identified at their Reykjavik facility.