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December 13, 2022December 13, 2022 – Idacio (adalimumab-aacf), a tumor necrosis factor (TNF) blocker biosimilar to Humira, has been approved by the FDA for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, and plaque psoriasis.
- The product label for Idacio carries a boxed warning to alert health care professionals and patients of the increased risk of serious infections and malignancies.
- The FDA approval of Idacio is based on clinical data that demonstrates Idacio is biosimilar to Humira.
- Idacio is administered via subcutaneous injection.
- Common adverse reactions (incidence >10%) include infections (e.g. upper respiratory, sinusitis), injection site reactions, headache, and rash.
- Idacio is the eighth FDA-approved Humira biosimilar, following the approvals of Yusimry (adalimumab-aqvh) in 2022, Hulio (adalimumab-fkjp) in 2020, Abrilada (adalimumab- afzb) in 2019, Hadlima (adalimumab-bwwd) in 2019, Hyrimoz (adalimumab-adaz) in 2018, Cyltezo (adalimumab-adbm) in 2017, and Amjevita (adalimumab-atto) in 2016.