Humira becomes Boehringer's first biosimilar approved in Europe
The European Commission followed in the footsteps of the US Food and Drug Administration (FDA) by approving the Humira (adalimumab) biosimilar being developed by privately-owned German drugmaker Boehringer Ingelheim.
Humira, an inflammatory diseases treatment developed by US drugmaker AbbVie (NYSE: ABBV), is the world’s top-selling drug but it is set to face biosimilar competition in Europe from October 2018, when its Supplementary Protection Certificate expires, with the likes of Boehringer now ready to steal market share.
The German pharma major has given its biosimilar to Humira the name Cyltezo, and has backed it up with a strong data package supporting its similarity to the reference drug, persuading the FDA to approve it in August, and now the European regulator to do the same.
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