Fresenius Kabi secures US FDA approval for its adalimumab biosimilar

By Jane Byrne

- Last updated on GMT

© GettyImages/Hailshadow
© GettyImages/Hailshadow

Related tags Biosimilars Fresenius kabi Fda Humira

Fresenius Kabi’s citrate-free biosimilar, Idacio (adalimumab-aacf) has been approved by the US FDA.

The adalimumab biosimilar is set to launch commercially in the US in a self-administered prefilled syringe and a self-administered pre-filled pen next year.  It is the company’s second approved US biosimilar and one that is set to launch in that market in July 2023, in accordance with the patent settlement agreement with AbbVie. 

A tumor necrosis factor (TNF) blocker, Idacio is designed to treat chronic autoimmune diseases for all eligible indications of the reference product, Humira (adalimumab) including rheumatoid arthritis, plaque psoriasis, Crohn's disease, ulcerative colitis, psoriatic arthritis, hidradenitis suppurativa, ankylosing spondylitis, juvenile idiopathic arthritis, and uveitis. 

Since its first launch in 2019, Idacio has been approved and commercialized in over 37 countries around the world. 

The authorization from the US Food and Drug Administration (FDA) for Idacio is based on a review of a data package and the totality of evidence demonstrating a similar analytical profile, pharmacokinetic, efficacy, safety, and immunogenicity to the reference adalimumab product. 

Commenting, Fresenius Kabi’s chief operating officer, said: “In the US, we are a leading manufacturer of small-molecule injectable medicines. This second US biopharmaceutical approval serves to broaden and diversify our US portfolio.”   

September this year saw the FDA also approve Fresenius Kabi’s pegfilgrastim biosimilar, Stimufend. That drug is aimed at patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. The company expects to launch the product in the US in a prefilled syringe and in an on-body injector early next year.

Related topics Markets & Regulations Biosimilars

Related news

Show more

Follow us