Teva Pharmaceuticals, a U.S. subsidiary of Teva Pharmaceutical Industries Ltd. (TEVA), along with Alvotech (ALVO), has announced the release of Simlandi (adalimumab-ryvk) injection in the United States. Simlandi serves as an interchangeable biosimilar to Humira and is used for the treatment of various 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.
The U.S. Food and Drug Administration (FDA) has approved Simlandi as the first high-concentration, citrate-free biosimilar to Humira, with interchangeability exclusivity for the 40mg/0.4mL injection.
In August 2020, Teva and Alvotech entered into a strategic partnership for the exclusive commercialization of five of Alvotech's biosimilar product candidates. This collaboration was expanded in July 2023 to include two additional biosimilars and new formulations of two previously partnered products.
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