The US Food and Drug Administration (FDA) has granted approval for Alvotech and Teva Pharmaceuticals’ SIMLANDI (adalimumab-ryvk) injection, an interchangeable biosimilar to Humira, for a range of conditions.

SIMLANDI can be used to treat adult ankylosing spondylitis, adult hidradenitis suppurativa, adult plaque psoriasis, adult psoriatic arthritis, adult ulcerative colitis, adult uveitis, Crohn’s disease, juvenile idiopathic arthritis and rheumatoid arthritis,

The approval positions SIMLANDI as the first high-concentration, citrate-free biosimilar with interchangeability status in 40mg/0.4ml injection.

Alvotech’s partner, Teva, will exclusively market the biosimilar in the US, leveraging its sales and marketing infrastructure.

SIMLANDI’s distinction lies in its high-concentration formulation, which aligns with the preference of approximately 88% of US adalimumab prescriptions. This interchangeability allows for pharmacy-level substitution without the need to consult the prescriber, akin to the substitution of generic drugs for branded ones.

The strategic collaboration between Alvotech and Teva, initiated in August 2020, has expanded to include seven biosimilar product candidates and new presentations of existing assets.

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Alvotech is responsible for the development and production of the products while Teva manages marketing in the US.

The FDA’s approval was supported by comprehensive evidence from a clinical development programme and analytical, non-clinical data.

The clinical findings comprised data from a Phase I AVT02-GL-101 study and two Phase III studies, AVT02-GL-301 and AVT02-GL-302.

These studies demonstrated SIMLANDI’s pharmacokinetic similarity, efficacy, safety and immunogenicity in comparison to Humira.

Teva Global research and development executive vice-president and chief medical officer Dr Eric Hughes stated: “The approval of SIMLANDI marks the first high-concentration, citrate-free biosimilar to Humira with IC status [listed, or under consideration for listing, as interchangeable with one or more other drug products].

“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 US.”