Amgen’s Biosimilar Adalimumab First To EU Nod But No Launch

Amgen’s biosimilar version of the anti-TNF adalimumab has become the first to receive an EU positive opinion but the company has no plans to launch the product this year.

The EU’s CHMP has granted a positive opinion on marketing ABP 501, Amgen Inc.’s biosimilar version of AbbVie Inc.’s multi-blockbusting anti-TNF Humira (adalimumab), under two trade names for its full complement of indications.

The opinion, which generally paves the way for approval within three months, technically puts it in the lead of a...

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