Alvotech, Teva obtain FDA OK for Humira biosimilar
Alvotech and Teva have received permission from the Food and Drug Administration for 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 said.
In addition, Teva is Alvotech’s strategic partner for the exclusive commercialization of Simlandi in the United States.
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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% of U.S. prescriptions for adalimumab are for the high-concentration presentation, Teva said.
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, Teva noted.
"The approval of Simlandi marks the first high-concentration, citrate-free biosimilar to Humira with IC status,” said Eric Hughes, executive vice president of 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% 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.”
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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.