This marks the first biosimilar launched under the strategic partnership between the two companies.
SIMLANDI has been approved by the US Food and Drug Administration (FDA) as the first high-concentration, citrate-free biosimilar to Humira with interchangeability exclusivity for the 40mg/0.4ml injection.
It is indicated for the treatment of various adult inflammatory conditions, including rheumatoid arthritis in adults, psoriatic arthritis, juvenile idiopathic arthritis, and Crohn’s disease, among others.
In August 2020, Teva and Alvotech signed a strategic collaboration to exclusively commercialise five biosimilar product candidates of Alvotech.
The collaboration was extended in July last year to incorporate two other biosimilars and new presentations of two priorly collaborated products.
Alvotech is responsible for the development and manufacturing of these products, while Teva manages its exclusive commercialisation in the US using its sales and marketing capabilities.
The partnership leverages Teva’s extensive sales and marketing infrastructure to ensure the successful launch and distribution of SIMLANDI.
In April this year, the FDA approved another product SELARSDI (ustekinumab-aekn) injection, as a biosimilar to Stelara.
This product is intended for the treatment of moderate to severe plaque psoriasis and active psoriatic arthritis in adults and paediatric patients aged six years and older.
Teva US Market Access senior vice-president Thomas Rainey said: “We are proud to make SIMLANDI available in the US to patients and providers.
“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 US 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.”