Alvotech and Teva Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has approved SIMLANDI (adalimumab-ryvk) injection, as an interchangeable biosimilar to Humira, 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.

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. While both low-concentration and high-concentration strength biosimilars of Humira are marketed in the U.S., nearly 88% of U.S. prescriptions for adalimumab are for the high-concentration presentation. 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. In August 2020, Alvotech and Teva entered into a strategic partnership for the exclusive commercialization of five of Alvotech?s biosimilar product candidates, and in August 2023 the partners extended the partnership to include two additional biosimilars and two new presentations of previously partnered products. Alvotech handles development and manufacturing, and Teva is responsible for U.S. commercialization, which leverages Teva?s extensive experience and sales and marketing infrastructure.

SIMLANDI is the first interchangeable, high-concentration, citrate-free biosimilar approved under the strategic partnership. Both Alvotech and Teva expect to launch SIMLANDI in the U.S. imminently with interchangeability designation. The FDA approval of SIMLANDI was based on a totality of evidence, including analytical, non-clinical, and clinical data.

The clinical development program, included data from (i) AVT02-GL-101, a Phase I, multicenter, randomized, double blind, 3-arm study, to demonstrate pharmacokinetic (PK) similarity and compare safety and tolerability of SIMLANDI to Humira in healthy adult volunteers; (ii) AVT02-GL-301, Phase III, multicenter, double-blind, randomized, parallel-group active control study to demonstrate similar efficacy, and compare safety and immunogenicity of AVT02 versus Humira in patients with moderate-to-severe chronic plaque psoriasis and (iii) AVT02-GL-302, a Phase III, multicenter, randomized, double-blind, parallel-group study in moderate to severe chronic plaque psoriasis patients to demonstrate similar PK, and comparable efficacy, safety, and immunogenicity between patients receiving Humira and patients undergoing repeated switches between Humira and SIMLANDI.