Fresenius Kabi’s Idacio (biosimilar, adalimumab) Receives the US FDA’s Approval for the Treatment of Chronic Autoimmune Diseases
Shots:
- The US FDA has approved citrate-free adalimumab biosimilar, Idacio for chronic autoimmune diseases. The product is expected to be available in the US in July 2023 as a self-administered prefilled syringe and pre-filled pen (autoinjector)
- The approval was based on a review of a comprehensive data package & totality of evidence that demonstrated a similar analytical profile, PK, efficacy, safety, and immunogenicity over the adalimumab product
- Idacio is a tumor necrosis factor (TNF) blocker and a biosimilar to Humira. The product has been approved and commercialized in ~37 countries globally & has been developed by Fresenius Kabi SwissBioSim by using advanced analytical methods for multiple chronic conditions
Ref: Newswire Canada | Image: Fresenius Kabi
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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.
