> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# AbbVie Sues Amgen Over Humira Biosimilar
- URL: https://www.fdaweb.com/abbvie-sues-amgen-over-humira-biosimilar/
- Published: 2016-08-05T12:00:00.000Z
- Updated: 2026-09-14T21:21:55.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5136426

AbbVie has filed suit against Amgen to block its biosimilar version of AbbVie’s blockbuster arthritis therapy Humira. Amgen’s proposed copy would infringe at least 10 patents, AbbVie says in the [complaint](http://www.bigmoleculewatch.com/wp-content/uploads/2016/08/ded-1-99-cv-de431-1.pdf?ref=fdaweb.com), which seeks a court order to prevent Amgen from marketing its biosimilar.

Last month, an FDA advisory committee voted to recommend approval for Amgen’s biosimilar after agency reviewers concluded it was highly similar to the innovator product. “The comparison of the structural and functional properties of the clinical and commercial product lots of ABP 501 and U.S.-licensed Humira supports a demonstration that they are highly similar, notwithstanding minor differences in clinically inactive components,” an FDA [briefing document](http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ArthritisAdvisoryCommittee/UCM510293.pdf?ref=fdaweb.com) says.