Alvotech and Teva gain U.S. approval for SIMLANDI injection

The U.S. Food and Drug Administration (FDA) has approved Alvotech and Teva Pharmaceuticals’ 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. today, nearly 88 percent 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.

“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.”

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. We strongly believe that biosimilars are important in addressing inflationary pressures in the healthcare system across all markets, especially in the U.S. where biologics represent well over 40 percent of all pharmaceutical spending. 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.”

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.

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