Teva, Alvotech announce Simlandi injection now available in U.S.

Teva Pharmaceuticals (TEVA) and Alvotech (ALVO), “announced the availability of SIMLANDI injection in the U.S., as an 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. SIMLANDI is approved by the U.S. Food and Drug Administration as the first high-concentration, citrate-free biosimilar to Humira with interchangeability exclusivity for the 40mg/0.4mL injection. While both low-concentration and high-concentration strength biosimilars of Humira are marketed in the U.S. today, nearly 88 percent of U.S. prescriptions for adalimumab are for the high-concentration presentation.Teva and Alvotech entered into a strategic partnership for the exclusive commercialization of five of Alvotech’s biosimilar product candidates in August 2020, and in July 2023, the collaboration was extended to include two additional biosimilars and new presentations of two previously partnered products. Alvotech handles development and manufacturing, while Teva is responsible for the exclusive commercialization in the U.S., which leverages Teva’s experience and extensive sales and marketing infrastructure. SIMLANDI is the first biosimilar launched under the strategic partnership, and in April 2024, the FDA approved SELARSDI injection for subcutaneous use, as a biosimilar to Stelara, for the treatment of moderate to severe plaque psoriasis and for active psoriatic arthritis in adults and pediatric patients 6 years and older.”