U.S. Commercialization Agreement with Quallent to Drive Patient Savings with First High-Concentration Citrate-Free Interchangeable Biosimilar to Humira (adalimumab) - Seite 2

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 percent of U.S. prescriptions for adalimumab are for the high-concentration presentations [1].

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.

Use of Trademarks
Humira is a registered trademark of AbbVie Biotechnology Ltd.

Sources
[1] Based on sales data from Symphony

About Teva

Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a global pharmaceutical leader with a category-defying portfolio, harnessing our generics expertise and stepping up innovation to continue the momentum behind the discovery, delivery, and expanded development of modern medicine. For over 120 years, Teva's commitment to bettering health has never wavered. Today, the company’s global network of capabilities enables its ~37,000 employees across 58 markets to push the boundaries of scientific innovation and deliver quality medicines to help improve health outcomes of millions of patients every day. To learn more about how Teva is all in for better health, visit www.tevapharm.com.