Amgen Moves Closer to Selling Competitor for AbbVie’s Humiraby
FDA advisers vote 26-0 for Amgen’s biosimilar to be approved
Humira is AbbVie’s top-selling drug at $14 billion last year
Amgen Inc.’s biosimilar version of the arthritis drug Humira cleared a regulatory hurdle, bringing it closer to entering the U.S. market and providing competition that could lower prices for AbbVie Inc.’s best-selling treatment.
A panel of Food and Drug Administration advisers voted 26-0 on Tuesday that the biosimilar, ABP 501, should be approved to treat seven chronic inflammatory conditions for which Amgen is seeking clearance, including rheumatoid arthritis and plaque psoriasis. Humira was AbbVie’s top-selling drug last year at $14 billion, accounting for more than 60 percent of total revenue.
FDA staff reviewing ABP 501 called it “highly similar” to Humira in a report released last week before the advisory panel meeting.
Patients and representatives from patient groups who testified at the panel meeting raised concerns several times that once biosimilars are more prevalent in the marketplace, there may be issues when patients are switched by their pharmacy or drug benefit manager to another company’s biosimilar. The concerns are that switching can cause patients to develop an allergic reaction or immunity to the drug so it’s less potent. The FDA didn’t ask the advisory panel to consider the switching issue, focusing instead on how Amgen’s biosimilar worked compared with AbbVie’s Humira.
The FDA hasn’t yet decided whether biosimilars can be switched automatically by a pharmacist without a doctor’s consultation, as now happens with many generics, to give patients the cheapest option. The agency is weighing what evidence it needs from biosimilar drugmakers that their products could be interchangeable with the original drugs they mimic.
“I’ve not seen such a disconnect between the charge to the committee and the concerns of the public,” Steven Solga, a gastroenterologist in Pennsylvania and panel member, said after the vote. “The disconnect is quite remarkable. It just wasn’t today’s committee’s charge, but these are important issues.”
A biosimilar is like a generic drug except it’s a near-copy of a complex biologic drug made from living organisms rather than chemicals. Generics have brought down the price of drugs they copy by as much as 80 percent, though biosimilars aren’t expected to have such a large effect since they take more resources to develop and manufacture. Studies have estimated savings from biosimilars, compared to the original drugs they mimic, of 10 percent to 50 percent, according to Rand Corp.
Congress gave the FDA the authority to approve biosimilars in 2010, and the FDA has since cleared two: Novartis AG’s version of Amgen’s Neupogen cancer drug and a copy of Johnson & Johnson’s arthritis drug Remicade that’s made by Pfizer Inc. and Celltrion Inc. On Wednesday, the advisory panel will consider Novartis’s biosimilar version of Amgen’s Enbrel, a competitor to Humira.
Amgen studied ABP 501 in plaque psoriasis and rheumatoid arthritis and is seeking to extrapolate the data to other conditions that Humira treats. The FDA is expected to decide whether to approve the biosimilar by Sept. 25. Litigation between Amgen and AbbVie is likely to prevent the drug from coming to market until at least 2018, according to Bloomberg Intelligence.