News & Trends - Pharmaceuticals
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.
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