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# FDA Reviewers Back Amgen’s Humira Biosimilar Candidate
- URL: https://www.fdaweb.com/fda-reviewers-back-amgens-humira-biosimilar-candidate/
- Published: 2016-07-11T12:00:00.000Z
- Updated: 2026-09-14T21:13:31.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5136131

FDA reviewers say an Amgen BLA (ABP 501) for a proposed biosimilar product referencing AbbVie’s Humira for treating arthritis is highly similar to the innovator product. The agency’s Arthritis Drugs Advisory Committee will review and vote on the submission 7/12.

“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. “Amgen provided extensive analytical and clinical pharmacology bridging data to scientifically justify the relevance of data obtained using EU-approved Humira to a demonstration of biosimilarity of ABP 501 to U.S.-licensed Humira. The submitted clinical pharmacology studies are adequate to (**1**) support the demonstration of PK similarity between ABP 501 and U.S.-licensed Humira, (**2**) establish the PK component of the scientific bridge to justify the relevance of the data generated using EU-approved Humira, (**3**) justify the relevance of the PK findings from the ABP 501 clinical program to the indications that were not directly studied in the ABP 501 clinical program for which U.S.-licensed Humira is licensed and for which Amgen is seeking licensure.”

Amgen’s data also showed that there are no clinically meaningful differences between ABP 501 and U.S.-licensed Humira, according to the document. Further, the data did not show any different safety or immunogenicity concerns compared to the reference product. “The applicant has also provided an extensive data package to address the scientific considerations for extrapolation of data to support biosimilarity to other conditions of use to support their request that ABP 501 should receive licensure, for the indications for which U.S.-licensed Humira is currently licensed and for which Amgen is seeking licensure,” it adds.