Amgen prepped to take first slice of AbbVie’s US Humira pie

Amgen is eyeing up a share of the $17+ billion US adalimumab market with the prospective launch of the first Humira biosimilar, Amjevita, later this month.

In its trend report ‘Drugs to watch 2023,’ Clarivate highlights the impending loss of exclusivity of AbbVie’s bestselling drug Humira (adalimumab). The monoclonal antibody has clocked in sales of more than $200 billion for AbbVie (and previously Abbott) since its launch in 2003, with 2021 sales alone pulling in $20.1 billion in sales, $17.3 billion from the US.

“All eyes will be on the expiry of a key US patent,” wrote Clarivate, “which could see Humira biosimilars launching in the United States throughout the year. Although the company still holds some essential manufacturing patents that are not due to expire until 2034, with Humira accounting for around 37% of AbbVie’s 2021 sales, the entry of adalimumab biosimilars is expected to have an impact on the company’s financials.”

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The report estimates sales could decline from to $13.9 billion in 2023, and $1.4 billion in 2028.

There are 10 players with approved biosimilars lined up to take a share of this market – Alvotech, Amgen, Boehringer Ingelheim, Coherus, Fresenius Kabi, Mylan, Pfizer, Organon, Sandoz, Viatris – but through a 2017 settlement with AbbVie, Amgen is prized to take advantage by being first to market months ahead of the pack.

“We worked hard to have a biosimilar ready approved and ready to go,” Amgen CEO Bob Bradway told investors at last week’s JP Morgan Conference. “We expect to launch on January 31. We expect that we’ll launch with a parity formulary position in most of the market and so we expect that will pave the way for some adoption over time.”

He added Amgen has an opportunity “of being recognized by the formularies of the big payers,” something he said will not be possible for many of the other biosimilar developers, and something that will keep the return on investment (ROI) at a suitable level despite inevitable price drops.

Referencing Amgen’s biosimilar launches in the US and elsewhere: “I don’t think there’s any question in our mind that we’re earning a return for our shareholders as well in excess of our cost of capital on the biosimilar program. But that comes from executing on time, on budget. And I would note that not everyone in the biosimilar industry has been able to complete their programs on time,” Bradway said.

“We’re a world leader in biologic process development, biologic manufacturing and we’re able to bring those capabilities to bear for the benefit of our biosimilar business. And in addition, we’re bringing forward biosimilars that are in therapeutic categories where we have strong existing relationships with payers and prescribers and we’re able to use that network for the benefit of our biosimilar brands. So we think that combination of attributes has enabled us, and will enable us, to continue to earn an attractive return here.”

However, he admitted the adoption of Amjevita was unlikely to be similar to the high rates seen by Amgen with its Avastin (bevacizumab) biosimilar Mvasi or its version of Herceptin (trastuzumab), Kanjinti, both of which launched in the US in 2019 and became major competitors to their reference products.

This was echoed by AbbVie’s CEO Rick Gonzalez, also speaking at JPM.

“One biosimilar will enter the market at the beginning of this year, but seven or eight will enter mid-year. What you ultimately will see is a certain level of price erosion in the first half of the year and a higher level of price erosion in the second half of the year when the environment is more competitive,” he said.

However, “We’ve now secured Humira formulary access for more than 90% of the U.S. covered lives this year. What that means is, essentially it will be on formulary with biosimilars, but there won’t be any difference between the biosimilar and Humira from a co-pay standpoint or any kind of a step editing.”

He continued: “So, essentially, it will compete head-to-head against those biosimilars, which is obviously a good position for us to be in. Based on that formulary access, obviously, the 10% that we don’t have, we’re likely to see fairly significant volume erosion in there.

“We’ll probably see some level of volume erosion in the 90% that we do have coverage, although I would say it’s probably going to be much more modest because there’s not as much motivation for those physicians to be able to make a change.”

Correction: this article originally said samsung bioepis was set to launch a Humira biosimilar but Hadlima will be launched by partner Organon.