Alvotech and Teva announced an expansion of their existing strategic partnership agreement relating to biosimilars products in the U.S. According to the announcement, the existing agreement includes AVT02, an interchangeable high-concentration biosimilar candidate for HUMIRA (adalimumab), and four other biosimilar candidates, including AVT04, a proposed biosimilar of STELARA (ustekinumab). The expansion relates to Teva’s “exclusive commercialization in the U.S. of two new biosimilar candidates and line extensions for two current biosimilar candidates in the partnership.” The announcement further states that the agreement includes “increased involvement by Teva regarding manufacturing and quality at Alvotech’s manufacturing facility” and that “Teva is actively supporting Alvotech on-site in Iceland to be fully ready for an FDA inspection.” In addition, “Teva has agreed to acquire subordinated convertible bonds to be issued by Alvotech” for $40 million, which Alvotech will use as part of the funding for continued development of its biosimilars pipeline over the near-term.
