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FDA Approves Alvotech’s Affordable Humira Alternative, Simlandi

FDA Approves Alvotech’s Affordable Humira Alternative, Simlandi

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"Affordable Humira Alternative"

Icelandic biomedical company Alvotech has been granted marketing approval by the FDA for its version of Humira, Simlandi, opening up new treatment opportunities for inflammatory diseases, including rheumatoid arthritis. The company’s introduction to the competitive U.S. pharmaceutical market could be a game-changer, providing a cost-effective alternative to one of the world’s top-selling prescription drugs.

Simlandi, or adalimumab-ryvk, becomes the first high-concentration, citrate-free biosimilar approved by the FDA for interchangeability. This promising alternative treatment allows reduced injection volumes and shorter injection times, in addition to potentially reducing injection-associated pain, which is particularly vital for patients requiring long-term injectable medications. The FDA’s interchangeability status also permits pharmacists to substitute Simlandi for Humira without a new healthcare provider prescription.

With the FDA’s marketing rights, Alvotech becomes the sole distributor of this high-concentration drug variant in the U.S. Although low-dose Humira analogs are available, the high-dose version provides an alternative for patients resistant or non-responsive to low-dose options, potentially reducing healthcare costs by negating the need for more expensive treatments and maintaining a strong market presence for high-dose Humira.

Teva Pharmaceutical, partnered with Alvotech in the U.S., will take the promotion and marketing reins for Simlandi – a significant undertaking considering Humira’s 2022 U.S. sales figures totaled a staggering ISK 1,680 billion.

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Alvotech’s CEO, Róbert Wessman, emphasized the pivotal role of FDA approval in expanding access to more affordable biopharmaceuticals across the globe. In the U.S., where such drugs make up over 40% of all medicine costs, Wessman believes introducing biosimilars like Alvotech’s products could greatly reduce these expenditures. The ultimate goal isn’t just creating innovative therapies, but ensuring their affordability and availability worldwide, underscoring the industry’s shared responsibility in alleviating patients’ financial pressures.

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