AILSA CHANG, HOST:
When a drug has been on the market for decades, it's supposed to lose patent protection, leaving room for generics, which force the drug's price down. But for Humira, the blockbuster rheumatoid arthritis drug, that shift hadn't happened. Now, after more than 20 years of pricing impunity, Humira is about to face cheaper competition. NPR pharmaceuticals correspondent Sydney Lupkin is here to explain the change. Hey, Sydney.
SYDNEY LUPKIN, BYLINE: Hey.
CHANG: OK. So what exactly is happening today with Humira?
LUPKIN: Its first competitor has finally launched a drug called Amgevita. Amgevita is a biosimilar, which is like a generic, but not exactly. Generics are chemical copies of drugs - think about lookalike blood pressure pills. Biosimilars are more complex. They're versions of drugs called biologics that are often antibodies or proteins. That's what Humira is - a biologic. It's been approved since 2002. But without a direct competitor, its maker, AbbVie, has been able to keep prices high. And there have been dozens of price hikes over the years. The latest one was a few weeks ago, on January 3. Humira now costs around $7,000 a month before insurance.
CHANG: Wow. Why haven't we had a Humira competitor like this until now?
LUPKIN: Well, there's a thicket of patents around Humira, and that has allowed AbbVie to maintain its monopoly. Here's Harvard Medical School's Ameet Sarpatwari.
AMEET SARPATWARI: You don't just patent the active ingredient. You can patent methods of use. You can patent methods of formulation. You can patent methods of manufacture.
LUPKIN: He says many drug companies have exploited the U.S. patent system, but called Humira the poster child for this strategy. Humira has been the best-selling pharmaceutical for a while, topping $20 billion in worldwide sales in 2021.
CHANG: Wait - so have all of these patents, like, blocked the FDA from approving competitors?
LUPKIN: No. Actually, the FDA has approved seven Humira biosimilars, including this one, but they couldn't launch. Amgevita won FDA approval in 2016, but there was litigation over the patents. Ultimately, there was a settlement that allowed Amgevita to launch today. That delay came with a big cost, however. Harvard's Sarpatwari worked on a study that showed Medicare would have saved more than $2 billion between 2016 and 2019 if Humira biosimilars were able to launch when they were approved.
CHANG: OK. So the big question - will this new version of Humira be any cheaper?
LUPKIN: Yes...
CHANG: OK.
LUPKIN: ...But it's a little complicated. Amgevita will launch with two prices, according to the drug company that makes it, which is Amgen. One is 5% cheaper than Humira, and the other is 55% cheaper. If your insurer or drug benefits manager negotiates rebates behind the scenes, they'll likely choose the higher price because, if they pick the deeper discount, they won't get a big rebate. So the savings in the beginning will probably be modest.
CHANG: So what do you think patients can expect at, like, the pharmacy counter?
LUPKIN: The company tells me Amgevita won't be available at pharmacies for another week or two, but don't expect your pharmacist to just switch your Humira prescription over to Amgevita. Here's Aaron Crittenden of GoodRx, a website that helps patients find prescription drug coupons.
AARON CRITTENDEN: You think about the traditional generic world - right? - where doctor writes a brand, and the pharmacy can just change it over to the generic. That's not the case here.
LUPKIN: That's because, with biosimilars, there can be different rules, and doctors will likely need to see big savings to want to push you over to this new drug. So right now, particularly with the fact that both of them are on the same tiers in a lot of benefit plans, the co-pay for the patient will be the same. But there are expected to be several more Humira biosimilars this summer, and that could start to move the needle on price.
CHANG: That's good news. That is NPR's Sydney Lupkin. Thank you, Sydney.
LUPKIN: You bet. Transcript provided by NPR, Copyright NPR.