Alvotech and Teva Pharmaceuticals announced the US Food and Drug Administration (FDA) approval for Simlandi (adalimumab-ryvk) injection, as an interchangeable biosimilar to Humira.
Humira (adalimumab) is a disease-modifying antirheumatic drug and monoclonal antibody, sold by US-based pharmaceutical company AbbVie.
Simlandi is indicated for juvenile idiopathic arthritis, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa and uveitis.
It is the first high-concentration, citrate-free biosimilar to Humira that has been granted an interchangeability status by the US health regulator.
Also, the drug qualifies for interchangeable exclusivity for the 40mg/0.4ml injection.
An interchangeable biosimilar may be substituted at the pharmacy without consulting the prescriber, much like generic drugs are routinely substituted for brand-name drugs.
Simlandi is the only interchangeable biosimilar to Humira with a high-concentration formulation and can be substituted for Humira at the pharmacy level, under the state pharmacy laws.
Teva Global R&D and chief medical officer executive vice president Eric Hughes said: “The approval of SIMLANDI marks the first high-concentration, citrate-free biosimilar to Humira with IC status.
“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.”
In August 2020, Alvotech and Teva teamed up for the exclusive commercialisation of five of Alvotech’s biosimilar product candidates, and extended their partnership last year, to include two additional biosimilars.
Alvotech will handle development and manufacturing, while Teva is responsible for US commercialisation, leveraging its experience and sales and marketing infrastructure.
The FDA approval of Simlandi is supported by the analytical, non-clinical and clinical data from the AVT02-GL-101, AVT02-GL-301, and AVT02-GL-302 clinical trials.
AVT02-GL-101 is a Phase 1 study designed to show the pharmacokinetic (PK) similarity, safety, and tolerability of Simlandi compared to Humira in healthy adult volunteers.
AVT02-GL-301 is a Phase 3 study that will establish the efficacy, and compare safety and immunogenicity of AVT02, Humira in patients with chronic plaque psoriasis.
AVT02-GL-302 is a Phase 3 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.
Alvotech chairman and CEO Robert Wessman said: “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 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.”
