Zachary Brennan
Senior Editor
When AbbVie CEO Richard Gonzalez sat before the House Committee on Oversight last week, calmly fending off questions about his mega-blockbuster Humira and its fortress of patents, the fate of any competition entering the US market before 2023 seemed all but sealed.
But what none of the representatives nor their 57-page report mentioned is that there is still one more biosimilar developer that has a shot at winning FDA approval for its version of Humira in September, and has yet to settle in court with AbbVie.
What’s more, this one — from Icelandic billionaire and former Actavis CEO Robert Wessman’s Alvotech — isn’t like the nine other biosimilars that may vie for market share.
First off, Wessman told Endpoints News in an exclusive interview on Monday, while the other biosimilars have targeted a version of Humira that’s a lower concentration than the version that currently dominates the US market, Alvotech is the first biosimilar developer to submit its application to the FDA for this higher concentration.
“So when those biosimilar companies enter in 2023, we expect that only 10% of Humira sales in the US – around 15 to 16 billion, only 10% will be [the lower concentration] 50 mg. We, on the other hand, were the first to get filing acceptance [with the FDA] of the higher concentration, so we can focus on 90% of the market when we come out,” Wessman said, noting he knows of one other biosimilar in the works for the higher concentration.
In its lawsuit to take down AbbVie’s Humira, in addition to highlighting the “minefield” of patents, Alvotech explains how AbbVie slow-played this higher concentrated version. AbbVie wrapped up testing of the less-painful 100 mg/ml formulation by 2010, won FDA approval for it in 2015, and then waited nearly three years after approval to bring it to market to stave off biosimilars, the suit says.
Another potential differentiator for Alvotech is that it’s currently working on the necessary trials to win an interchangeable designation from FDA for its Humira biosimilar. Wessman said such trials typically cost about $30-35 million. Boehringer Ingelheim in 2019 also completed the trials necessary to win an interchangeable designation for its biosimilar for the lower concentration of Humira but has yet to obtain the designation from FDA.
The designation will allow Alvotech to gain faster market share, Wessman noted, although like BI, the designation would be added after that initial approval.
“In the US, you cannot switch between strengths without the doctor’s consent,” he added. “Chronic use in US means that new uptake of biosimilars without interchangeability will focus on new patients because the regulatory environment doesn’t allow those switches mid-treatment unless the doctor approves it.”
Meanwhile, AbbVie is clearly feeling the heat as it sued Alvotech recently, claiming the only reason that Alvotech developed a biosimilar for the higher concentration of Humira is because it took a shortcut by poaching an employee from AbbVie with the manufacturing know-how.
Wessman said the accusations are “without merit.”
“The individual in question was already a floor shop operator and left, and they didn’t do anything until a year after he left Alvotech and he’s still in the biosimilar/biotech industry and has not been sued,” he said.
Also, he noted that AbbVie should’ve sued Alvotech in Virginia, where the US part of the company is based, but that court tends to be faster than other courts in the US in coming to decisions. So instead AbbVie went to its “home court” in Chicago, he said.
Moving forward, the timeline for when the patent and trade secret suits between the two companies will wrap up is unknown, Wessman said. But he said he thinks Congress needs to take a closer look at what changes can be made so companies that abuse the patent system, like AbbVie, aren’t rewarded with tens of billions of dollars for a drug they didn’t invent.
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