Alvotech and Teva Pharmaceuticals disclosed that under the recently announced U.S. strategic partnership agreement, Alvotech will manufacture its high-concentration interchangeable biosimilar to Humira (adalimumab) for Quallent Pharmaceuticals, in alignment with its U.S. commercialization agreement with Teva. The interchangeable biosimilar will be distributed under Quallent?s private label. The U.S. Food and Drug Administration (FDA) approved Alvotech?s biosimilar on February 24, 2024, as a high-concentration interchangeable biosimilar to Humira, for the treatment of adult rheumatoid arthritis, juvenile idiopathic arthritis, adult psoriatic arthritis, adult ankylosing spondylitis, Crohn?s disease, adult ulcerative colitis, adult plaque psoriasis, adult hidradenitis suppurativa and adult uveitis.

This is the first high-concentration, citrate-free biosimilar to Humira granted an interchangeability status by the FDA and Alvotech will have interchangeable exclusivity for the 40mg/0.4mL strength. Nearly 88% of U.S. prescriptions for adalimumab are for the high-concentration presentations. In August 2020, Alvotech and Teva entered into a strategic partnership for the exclusive commercialization of five of Alvotech?s biosimilar product candidates, and in August 2023 the partners extended the partnership to include two additional biosimilars and two new presentations of previously partnered products.

Alvotech handles development and manufacturing, and Teva is responsible for U.S. commercialization, which leverages Teva?s extensive experience and sales and marketing infrastructure. Alvotech?s high concentration interchangeable biosimilar to Humira (adalimumab) was the first biosimilar approved under the strategic partnership, and Teva expects to launch it to patients in the U.S. imminently.