Amgen is seeking permission to market ABP 501 - potentially the first biosimilar of AbbVie’s multi-billion-dollar blockbuster Humira - in the US for inflammatory conditions.
The firm said its submission includes data from Phase III studies in both moderate-to-severe plaque psoriasis and moderate-to-severe rheumatoid arthritis, showing clinical equivalence to Humira (adalimumab) as well as a comparable safety profile.
The Biologics License Application also includes data that support switching patients to its drug, an anti-TNF-_ monoclonal antibody with the same amino acid sequence as Humira, which also comes with the same dosage form and strength.
Biosimilars are copies of approved off-patent biologic medicines that demonstrate no clinically meaningful differences in terms of safety, quality and efficacy to their reference drugs.
Priced at up to 30% cheaper than their branded counterparts, biologics are widely believed to hold great promise in securing more affordable healthcare.
Novartis’ Zarxio, a biosimilar of Amgen’s white blood cell booster Neupogen, was the first biosimilar to win US approval back in March.