Alvotech (ALVO) and Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (TEVA), announced that the U.S. FDA has approved SIMLANDI (adalimumab-ryvk) injection, as an interchangeable biosimilar to Humira.
SIMLANDI 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.
As with Humira, Simlandi is 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.
In 2023, Humira was one of the highest-grossing pharmaceutical products in the world, with sales in the U.S. of nearly $12.2 billion. Teva is Alvotech's strategic partner for the exclusive commercialization of SIMLANDI in the United States.
"Biosimilars create opportunities for cost savings across the healthcare system and introduce additional treatment options for patients. This approval marks an important milestone for Teva and Alvotech's partnership to collaborate on seven biosimilars and expand the availability, access, and uptake of biosimilars in the U.S." said Dr. Eric Hughes, Executive Vice President Global R&D and Chief Medical Officer at Teva.
Robert Wessman, Chairman and CEO of Alvotech, added,"This approval is an important milestone in Alvotech's journey to offer broader access worldwide to more affordable biologics, following approvals of our biosimilars in other global markets. An interchangeable citrate-free, high-concentration biosimilar adalimumab has the potential to change the market dynamics in a rapidly evolving environment for biosimilars in the U.S."
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