AbbVie’s Humira was the world’s best-selling drug for many years. It now faces competition for knockoffs that cost a fraction of its price.

David J. Philip/AP

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David J. Philip/AP

AbbVie’s Humira was the world’s best-selling drug for many years. It now faces competition for knockoffs that cost a fraction of its price.

David J. Philip/AP

Humira has been one of the best-selling drugs in the world for over two decades. But thanks to a few new imitators, including one sold at entrepreneur Mark Cuban’s online pharmacy, his reign may be ending.

Humira is an injectable drug approved in 2002 that treats a number of diseases, including Crohn’s disease and rheumatoid arthritis. The drug is popular with patients but has a list price of nearly $7,000 a month, according to GoodRx, a website that helps patients find discounts on pharmaceuticals.

Even with insurance, the drug, manufactured by AbbVie, can be quite expensive.

For years there was no direct competition, mainly because the company protected the drug with a forest of patents. Humira generated $21 billion in sales in 2022 alone, according to AbbVie’s annual financial statement.

« I think it’s fair to say that Humira is the poster boy for what ails the system, and that’s a huge amount of patents protecting various aspects of the molecule, some of which are undeserved, » he says. Ameet Sarpatwari, deputy director of the program on regulation, therapeutics and law at Harvard Medical School.

In 2016 the The Food and Drug Administration has approved Amjevita, the first drug that was a close copy of Humira. Humira is an antibody drug and copies are not identical. Alternative medicines are called biosimilars.

Patents and PBMs hinder competition for Humira

But the first biosimilar Humira and the handful that followed couldn’t hit the market until this year due to litigation over all those patents.

As of this month, there are nine Humira biosimilars for sale, but so far, not many people are buying them. Many of them cost nearly as much as Humira, and lower-priced options aren’t necessarily always covered by insurance.

“The reason prices haven’t changed overnight is because we have a byzantine, opaque and in some ways perverse pharmaceutical system from the manufacturer through what is called the pharmacy benefits manager all the way to the pharmacy,” says Sarpatwari.

That pharmacy benefits manager he talks about decides which drugs you can get with your insurance card and how much you pay for them. These middlemen buy drugs and then get some of that money back from the drug companies through discounts. The size of the discount is usually secret, but it often influences which pharmaceuticals get the best market share.

So even if a competitor drug is priced lower, it may not end up on the drug menu, or formulary, that your insurance will pay for, he says Karen Van Nuys, senior fellow at the Schaeffer Center for Health Policy and Economics at the University of Southern California.

« Who will the pharmacy allowance manager enter into the form? » she says. « And in many cases, they are thought to prefer the higher discount drug. »

The low price of a rival to Humira could help it break through

That may change for Humira due to a biosimilar called Yusimry.

Drug, made by Coherus BioSciences, just launched and retailing for around $1,000 a month. It will be even cheaper through Mark Cuban’s online pharmacy Additional costwhere there will be no discount for a pharmaceutical benefits manager and the price is approximately $570 per month plus shipping and handling.

Its list price is cheaper than any other Humira biosimilar on the market, almost all above $6,000, according to data from Good Rx.

Chris Slavinsky, Chief Business and Legal Officer of Coherus BioSciences says a rock bottom price is needed to help patients. Yusimry is the company’s first foray into medicines administered outside of a hospital setting.

« How can we take that, yet stay true to our core values ​​of access to driving? » Slavinsky says. « And that became the seed that eventually became the low list price. »

Coherus has rated its biosimilar so low that pharmaceutical benefits managers may choose to forgo Humira’s big discounts.

This is why Humira is so popular. Humira and similar drugs account for such a large chunk of drug spending that switching patients to Yusimry could allow plans to lower premiums while saving up to 11 percent on total drug spending, he says Richard Evans, a pharmaceutical industry veteran who runs drug pricing data company SSR Health.

And employers who choose employee health insurance plans annually are concerned about saving money on Humira.

« You know, it really pays to be aggressive to try to take that 11% of your spending and reduce it as much as possible, because any savings you can create and be put back into lower premiums, » says Evans.

So if insurance plans are competing for customers by offering lower premiums, they may have to make adjustments and include Yusimry on their forms.

Time will tell if Humira’s cheaper challengers catch on.