FDA approves Simlandi as third interchangeable Humira biosimilar
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Key takeaways:
- Simlandi is the first interchangeable, citrate-free Humira biosimilar available in a high concentration.
- The drug is the tenth Humira biosimilar approved by the FDA, and the third to achieve interchangeable status.
The FDA has approved Simlandi as the third interchangeable biosimilar to Humira following a rejection in April 2023 stemming from issues at the developer’s manufacturing facility.
Simlandi (adalimumab-ryvk) is the first interchangeable, citrate-free Humira (adalimumab, AbbVie) biosimilar to be available in a high-concentration formulation, according to a joint statement from Alvotech, the drug’s manufacturer, and Teva Pharmaceutical Industries, its biosimilar commercialization partner in the United States.
“We strongly believe that biosimilars are important in addressing inflationary pressures in the health care system across all markets, especially in the U.S., where biologics represent well over 40% of all pharmaceutical spending,” Robert Wessman, chairman and CEO of Alvotech, said in the release. “An interchangeable citrate-free, high-concentration biosimilar [for] adalimumab has the potential to change the market dynamics in a rapidly evolving environment for biosimilars in the U.S.”
Simlandi will qualify for interchangeable exclusivity as a 40 mg/0.4 mL injection, according to the release. Its approval comes after the FDA previously designated Cyltezo (adalimumab-adbm, Boehringer Ingelheim) and Abrilada (adalimumab-afzb, Pfizer) as interchangeable with Humira last year.
Interchangeability means pharmacies can substitute Simlandi for originator Humira without consulting prescribers — at least where such policies are allowed under state law.
The FDA had previously denied Alvotech’s application for Simlandi — then known as AVT02 — in April 2023 based on “deficiencies” found during an inspection at the company’s manufacturing facility in Reykjavik, Iceland. The FDA at the time stated in a complete response letter to Alvotech that a satisfactory resolution to these deficiencies would be required before any approval.
That rejection scuttled plans to release the biosimilar in the United States on July 1, 2023. Following Simlandi’s approval, both Alvotech and Teva expect the drug to make its U.S. debut “imminently,” according to the release.
Overall, Simlandi is the tenth Humira biosimilar to be approved by the FDA. Humira has consistently ranked as one of the highest-grossing pharmaceutical products in the world, with U.S. sales reaching nearly $12.2 billion in 2023.
Simlandi has been approved to treat rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa and uveitis.
The FDA based its approval on “analytical, non-clinical and clinical data” from a phase 1 study in healthy volunteers, and two phase 3 trials comparing the biosimilar to originator Humira patients with moderate to severe chronic plaque psoriasis, according to the release.
“The approval of Simlandi marks the first high-concentration, citrate-free biosimilar to Humira with [interchangeable] status,” Eric Hughes, MD, PhD, chief medical officer and executive vice president of global research and development at Teva, said in the release. “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.”
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