FDA approves Alvotech and Teva’s Simlandi as interchangeable Humira biosimilar
Simlandi is approved to treat multiple indications, including rheumatoid arthritis and Crohn’s disease.
The US Food and Drug Administration (FDA) has approved Alvotech and Teva’s Simlandi (adalimumab-ryvk) injection as an interchangeable biosimilar to AbbVie’s Humira (adalimumab).
Simlandi has been approved by the regulator to treat rheumatoid arthritis, idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa and uveitis.
Biosimilars, according to the FDA, are biological products that are highly similar to and have no clinically meaningful differences from an existing FDA-approved reference product. The drugs have no clinically significant differences in terms of safety or effectiveness from the reference product, but they potentially lower healthcare costs.
Simlandi is the first high-concentration, citrate-free biosimilar to Humira that has been granted an interchangeability status by the FDA, the companies outlined, adding that almost 88% of US prescriptions for adalimumab are for the high-concentration presentation
Robert Wessman, chairman and chief executive officer of Alvotech, said: “We strongly believe that biosimilars are important in addressing inflationary pressures in the healthcare system across all markets, especially in the US, 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 US.”
The FDA’s decision on Simlandi was based on a totality of evidence, including analytical, non-clinical and clinical data. This included data from the late-stage AVT02-GL-301 trial, in which the product demonstrated similar efficacy and comparable safety and immunogenicity to Humira in patients with moderate-to-severe chronic plaque psoriasis.
26th February 2024
