Teva and Alvotech’s Adalimumab Biosimilar Receives Interchangeable Status at FDA

On February 23rd, 2024, Alvotech and Teva announced FDA’s approval of SIMLANDI (adalimumab-ryvk), the first high-concentration and citrate-free biosimilar interchangeable with Humira. SIMLANDI injection was approved for nine indications—rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s Disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurative, and uveitis.

The approval follows Alvotech’s successful resubmission of a Biologics License Application announced on September 20, 2023 for the monoclonal antibody AVT02. Prior to FDA’s approval, AVT02 had already been on the market in various other countries. As we reported previously, it is marketed as CIPTUNEC and ARDALICIP in Australia; HUKYNDRA in the European Union, Norway, Iceland, Lichtenstein, the United Kingdom, and Switzerland; and SIMLANDI in Canada and Saudi Arabia. Teva is the exclusive partner of Alvotech for the commercialization of SIMLANDI in the United States, and the launch is expected imminently.