Skip to NavigationSkip to content

Amgen’s Humira biosimilar candidate “highly similar” to originator, says FDA

Published on 08/07/16 at 02:12pm

A report from a meeting of the US Food and Drug Administration’s (FDA) Arthritis Advisory Committee has concluded that Amgen’s biosimilar candidate of the world’s bestselling drug, AbbVie’s Humira (adalimumab), is “highly similar” to the originator.

The drug, which treats conditions such as rheumatoid arthritis and psoriasis, records sales in the tens of billions each year. AbbVie has faced legal action in recent times for attempting to block biosimilar versions of Humira getting to market.

The FDA had announced in mid-June that they this committee would review the data supporting Amgen’s biologics licence application for ABP 501. At the time, R&D head Sean E. Harper said: “We look forward to discussing the comprehensive data package for ABP 501 with the members of the Committee.”

The Committee came to conclude that the biosimilar bore enough similarities to the original to label them as “highly similar”. They write: “The comparison of the structural and functional properties of the clinical and commercial product lots of ABP 501 and US-licensed Humira supports a demonstration that they are highly similar, notwithstanding minor differences in clinically inactive components.”

Importantly, the committee accepts data showing that the single transition from Humira to ABP 501, did not result in different safety or immunogencitiy, compared to when the patient stays on Humira. They add: “This would support the safety of a clinical scenario where non-treatment naïve patients may undergo a single transition to ABP 501.”

The committee concludes that the extensive data package provided by Amgen supports their request that ABP 501 “should receive licensure for the indications for which US-licensed Humira is currently licensed.”

A decision on Amgen’s biologics licence application is expected later this year.

Sean Murray

Mission Statement
Pharmafile.com is a leading portal for the pharmaceutical industry, providing industry professionals with pharma news, pharma events, pharma service company listings and pharma jobs,
Site content is produced by our editorial team exclusively for Pharmafile.com and our industry newspaper Pharmafocus. Service company profiles and listings are taken from our pharmaceutical industry directory, Pharmafile, and presented in a unique Find and Compare format to ensure the most relevant matches