Humira Biosimilar Simlandi Now Available in the US


Teva Pharmaceuticals and Alvotech announced the availability of Simlandi (adalimumab-ryvk) injection in the US as an interchangeable biosimilar to Humira. Simlandi is indicated for the treatment of adult plaque psoriasis and adult hidradenitis suppurativa, as well as adult rheumatoid arthritis, juvenile idiopathic arthritis, adult psoriatic arthritis, adult ankylosing spondylitis, Crohn’s disease, adult ulcerative colitis, and adult uveitis.

Teva is Alvotech’s strategic partner for the exclusive commercialization of Simlandi in the United States.

Simlandi, which received FDA approval in February 2024, is the first high-concentration, citrate-free biosimilar to Humira that has been granted an interchangeability status by the FDA, and will qualify for interchangeable exclusivity for the 40mg/0.4ml injection. While both low-concentration and high-concentration strength biosimilars of Humira are marketed in the US today, nearly 88 percent of US prescriptions for adalimumab are for the high-concentration presentation.1

“We are proud to make Simlandi available in the U.S. to patients and providers,” Thomas Rainey, Senior Vice President, U.S. Market Access at Teva, said in a company news release. “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.”

An interchangeable biosimilar may be substituted at the pharmacy without consulting the prescriber, much like generic drugs are routinely substituted for brand name drugs. As the only interchangeable adalimumab biosimilar with the high-concentration formulation, Simlandi can be substituted for Humira at the pharmacy level, subject to state pharmacy laws.

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 US. Simlandiis the first biosimilar launched under the strategic partnership. 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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