A US Food and Drug Administration's advisory committee is supporting the approval of Amgen's biosimilar of AbbVie's biologic Humira, the world second best-selling drug.
The panel voted 26-0 in favour of Amgen drug, dubbed ABP 501, on the back of studies conducted in both moderate-to-severe plaque psoriasis and moderate-to-severe rheumatoid arthritis, which met their primary goals in showing clinical equivalence to Humira (adalimumab).
Safety and immunogenicity were also comparable, and the submission also included data to support the transition of adalimumab patients to the biosimilar, the firm previously noted.
Humira, an anti-TNF monoclonal antibody, pulls in annual sales of nearly $15 billion across its range of indications for inflammatory diseases. While pricing data aren't yet available, Amgen's offering is expected to be significantly cheaper and thus has the potential to generate substantial savings for healthcare providers.
"We're pleased with today's unanimous vote of the FDA's Arthritis Advisory Committee to recommend approval of ABP 501 in all available indications to the reference product," said Sean Harper, executive vice president of R&D at Amgen. "The Committee's favourable vote is an exciting step toward recognising ABP 501 as an important treatment option for patients with inflammatory diseases."
Nevertheless, a launch could be some way off. According to the Wall Street Journal, Evercore ISI analyst Mark Schoenebaum believes the earliest Amgen could roll out ABP 501 is March 2017, but at a risk of of infringing patents that AbbVie claims are valid until 2022. Wall Street analysts are expecting a court battle following a launch between 2018 and 2022, the paper reports.