Teva and Alvotech Launch SIMLANDI® Injection in the U.S.

Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd., and Alvotech have announced the release of SIMLANDI (adalimumab-ryvk) injection in the U.S. market. SIMLANDI is recognized as an interchangeable biosimilar to Humira® and is designed for treating a range of conditions including 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.

Thomas Rainey, Senior Vice President of U.S. Market Access at Teva, expressed pride in making SIMLANDI available to U.S. patients and healthcare providers. He emphasized that biosimilars like SIMLANDI can offer significant cost savings across the healthcare system. Rainey also noted that SIMLANDI is the first high-concentration, citrate-free biosimilar to Humira in the U.S. market. Teva is committed to ensuring that SIMLANDI, as well as six other biosimilars they plan to introduce by 2027, are accessible to patients.

SIMLANDI has received approval from the U.S. Food and Drug Administration (FDA) as the first high-concentration, citrate-free biosimilar to Humira with interchangeability exclusivity for the 40mg/0.4mL injection. The majority of U.S. prescriptions for adalimumab, around 88 percent, are for the high-concentration formulation.

Anil Okay, Chief Commercial Officer of Alvotech, highlighted the importance of providing U.S. patients with access to cost-effective, quality biosimilars such as SIMLANDI. Okay believes that biosimilars can play a significant role in reducing inflationary pressures on healthcare providers and patients.

Teva and Alvotech formed a strategic partnership in August 2020 for the exclusive commercialization of five of Alvotech’s biosimilar product candidates. This collaboration was further extended in July 2023 to include two additional biosimilars and new presentations of two previously partnered products. Alvotech is responsible for development and manufacturing, while Teva manages the exclusive commercialization in the U.S. utilizing its extensive sales and marketing infrastructure. SIMLANDI is the first product launched under this partnership.

In April 2024, the FDA approved another product from this collaboration, SELARSDI (ustekinumab-aekn) injection, for subcutaneous use. This biosimilar to Stelara® is intended for treating moderate to severe plaque psoriasis and active psoriatic arthritis in adults and pediatric patients aged 6 years and older.

Teva Pharmaceutical Industries Ltd. is a global leader in the pharmaceutical industry, known for its diverse portfolio and commitment to innovative medicine. With over 120 years of experience, Teva leverages its global network and capabilities to deliver quality medicines to millions of patients. Alvotech, founded by Robert Wessman, is a biotech company dedicated to developing and manufacturing biosimilar medicines. It aims to be a global leader in the biosimilar market by providing high-quality, cost-effective products facilitated by an integrated approach and extensive in-house capabilities.

Alvotech’s pipeline includes eight biosimilar candidates targeting autoimmune disorders, eye disorders, osteoporosis, respiratory diseases, and cancer. The company has established a network of commercial partnerships to extend its reach globally, covering markets in the United States, Europe, Japan, China, and other regions. These partnerships allow Alvotech to leverage local expertise and provide effective biosimilar medicines worldwide.