Teva Pharmaceuticals and Alvotech, announced the availability of SIMLANDI (adalimumab-ryvk) injection in the US, 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.
“We are proud to make SIMLANDI available in the U.S. to patients and providers,” said Thomas Rainey, Senior Vice President, U.S. Market Access at Teva. “Biosimilars create opportunities for cost savings across the healthcare system, and SIMLANDI’s launch now offers the first citrate-free, high-concentration biosimilar to be designated interchangeable to Humira in the U.S. market. We will be working with payors to ensure access to SIMLANDI, as well as the six other biosimilars we are committed to bringing to market by 2027.”
SIMLANDI is approved by 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. 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.1
“It is a great pleasure to be able to offer U.S. patients access to SIMLANDI, the only citrate-free, high-concentration interchangeable biosimilar to Humira. We look forward to increasing the availability of cost-effective quality biosimilars in the U.S., as they can be an important contributor to reduced inflationary pressure for healthcare providers and patients,” said Anil Okay, Chief Commercial Officer of Alvotech.
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 (ustekinumab-aekn) 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.
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