In September, the US Food and Drug Administration (FDA) approved the country’s first biosimilar version of the TNF-inhibiting monoclonal antibody Humira in the form of Amgen’s Amjevita.
The earliest the product could arrive in the US is March 22 next year, after the US Court of Appeals for the Federal Circuit ruled in July that a biosimilar applicant must provide at least 180-days’ notice to the reference product sponsor from the date of FDA approval before a commercial launch.
However, Amgen’s CEO Bob Bradway admitted AbbVie’s adalimumab dominance is likely to remain unthreatened throughout 2017 as the firm is unlikely to launch Amjevita at risk.
“As you know, we're in litigation with AbbVie over Amjevita, and it's safe to say that there will be more litigation before there's a launch,” he told stakeholders during a financial conference call last week.
“Given the pace of that litigation, it's unlikely that this matter will be clarified in time for us to launch in 2017.”
AbbVie - which last year clocked in US Humira sales of $8.4bn - has been vocal about protecting its bestseller, claiming it is protected by dozens of formulation, manufacturing and method of treatment patents which would keep biosimilars at bay until at least 2022.
In January, AbbVie successfully rebuffed a legal challenge by Amgen over two formulation patents, but commentators said at the time the fight was “far from over.” Meanwhile, the firm has also been embroiled in legal disputes with other adalimumab developers, including Coherus BioSciences which successfully overturned one of AbbVie’s patents regarding dosing regimen in May this year.
AbbVie preliminary injunction threat
AbbVie also presented its Q3 results last week, and CEO Richard Gonzalez said it is no surprise Amgen would be unlikely to launch at risk.
“When you look at the magnitude of our IP portfolio and you look at the risk of launching at risk against that portfolio, that would be a high-risk proposition for anyone,” he told investors.
“We've made our intentions very clear [that] we plan to enforce our IP against anyone who attempts to enter the marketplace, and that we would – if someone chose to make a decision to launch at risk - seek a PI [preliminary injunction].”
For the quarter ending September 30, total Humira sales were just over $4bn. Over $2.6bn came from the US, representing a 16.7% growth on the same period 2015.