Israel’s Teva Pharmaceuticals received approval from the Food and Drug Administration for the SIMLANDI (adalimumab-ryvk) injection, for the treatment of a number of different forms of arthritis, colitis and Chron’s Disease, among others. The drug is developed together with Iceland’s Alvotech and its marketing could lead to billions in sales.
SIMLANDI is the first high-concentration, citrate-free biosimilar to Humira – a currently used medication – that has been granted an interchangeability status by the FDA.
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An interchangeable biosimilar is something that can be substituted at the pharmacy without consulting the prescriber, much like generic drugs are routinely substituted for brand name drugs.
Rheumatoid Arthritis, Juvenile Idiopathic Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Plaque Psoriasis, Hidradenitis Suppurativa, and Uveitis can all be treated in one way or another with this new medication.
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 approval of SIMLANDI marks the first high-concentration, citrate-free biosimilar to Humira with IC status,” said Dr. Eric Hughes, Executive Vice President Global R&D and Chief Medical Officer at Teva. “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.”
