Teva and Alvotech announced they have agreed to expand their existing strategic partnership agreement for the US with subordinated convertible bonds to be issued to Teva for USD$40M.
The expansion to the existing strategic partnership relates to exclusive commercialisation in the US by Teva of two new biosimilar candidates and line extensions of two current biosimilar candidates in the partnership, to be developed, and manufactured by Alvotech. The existing partnership includes: two US biosimilar candidates pending FDA approval:
- AVT02 (adalimumab), an interchangeable high-concentration biosimilar to AbbVie’s Humira®; and
- AVT04 (ustekinumab) biosimilar to Janssen’s Stelara®
The agreement also covers milestone payments and shared profits from the commercialization of the biosimilars. All other terms of the expansion remain confidential.
The partnership was entered into between Alvotech and Teva on 5 August 2020. On 6 January 2023, the two companies announced that the FDA accepted for review their BLA for AVT04, and on 12 June 2023 they reached a settlement and license agreement with Johnson & Johnson for AVT04.
On 12 June 2023, Alvotech and Teva reached a settlement and licence agreement with J&J regarding AVT04 (ustekinumab), biosimilar to Janssen’s Stelara®.