FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs

European Commission Approves Humira Biosimilar

April 17, 2019

European regulators gave the green light to Fresenius Kabi’s Idacio, a biosimilar of AbbVie’s blockbuster autoimmune treatment Humira (adalimumab).

It’s the first molecule in Fresenius’ biosimilars portfolio to win regulatory approval. The biosimilar will be available for marketing for all of Humira’s indications, ranging from Crohn’s disease to psoriatic arthritis.

Analysts predict that Humira biosimilars will shave up to $2 billion off AbbVie’s sales in Europe. Global sales of Humira reached almost $20 billion in 2018.

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