Fresenius Kabi gains TGA approval for new biosimilar

Pharma News: Fresenius Kabi secured TGA registration of Idacio, a biosimilar medicine to AbbVie’s Humira (adalimumab).

With global sales of US$20 billion in 2018, AbbVie’s Humira has been a target for a number of biosimilars.

The drug is an antibody treatment for a range of inflammatory conditions, including various forms of arthritis, inflammatory bowel disease and psoriasis.

Fresenius Kabi’s Idacio (adalimumab rch) is approved for:

• Rheumatoid arthritis as monotherapy or in combination with methotrexate
• Juvenile idiopathic arthritis – in combination with methotrexate is indicated for reducing the signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis
• Psoriatic arthritis – moderate to severe disease
• Ankylosing spondylitis
• Crohn’s disease in adults and children (≥ 6 years)
• Ulcerative colitis – moderate to severe disease
• Psoriasis in adults and children – active moderate to severe hidradenitis suppuratives (acne inversa)
• Uveitis – non-infectious intermediate, posterior and pan-uveitis

Other adalimumab biosimilars registered in Australia include Amgen’s Amgevita since 2017, Samsung Bioepis’ Hadlima since 2018 and Sandoz’s Hyrimoz since 2019.