AbbVie says manufacturing will be key differentiator between Humira's biosimilar competitors

With nearly a dozen companies lined up with biosimilar versions of Humira, AbbVie is trying to figure out the lay of the land in 2023, the dreaded year that the company loses of exclusivity for the world’s all-time best-selling drug, which has accumulated more than $200 billion in revenue.

It was a major topic for the company at the recent Morgan Stanley Global Healthcare Conference, where Chief Commercial Officer Jeff Stewart provided hints about how AbbVie is sizing up the competition.

As Stewart sees it, pharmacy benefit managers (PBMs) and payers will favor the most consistent, reliable suppliers. This bodes well for Amgen, the first company that will have a crack at competing in the Humira market as its biosimilar, Amjevita, is set to launch in January 2023.

“That’s absolutely in the consideration set of a PBM,” Stewart said. “With Amgen, they’ve been able to consistently supply globally, and so a payer will look at Amgen perhaps differently than some of the others in that second tier of the launches.”

Alternatively, Alvotech’s recent biosimilar manufacturing setback may prompt some extra questions for it and other competitors, Stewart suggested. Last week, the FDA revealed 13 observations from its inspection of Alvotech’s manufacturing site, which led the U.S. regulator to reject the Humira biosimilar, pushing its target date for a potential approval to December of this year.

“One of the biggest considerations from that notification that we saw with Alvotech is a little bit of, 'ha, OK, now that makes me nervous,' even if they can correct it,” Stewart said. “It sort of raises that continuity of supply with whoever I want to partner with from a biosimilar to a pretty high level.”

Alvotech has partnered with Teva for its Humira biosimilar launch in the U.S. Despite the setback, Alvotech said it expects to be ready for its July 2023 launch date.

While Amgen will be the first to launch with Amjevita, Boehringer Ingelheim has a key "interchangebale" designation for its Humira biosim Cyltezo. For drugs with the status, pharmacists can sub in the biosimilar for the reference brand at the pharmacy counter.

With so many companies launching Humira biosimilars in 2023—including Coherus, Fresenius Kabi, Pfizer, Samsung Bioepis, Sandoz, Viatris—differentiation will be key.

Meanwhile, the number of potential competitors flooding the market in the second half of the year also is complicating negotiations with payers over Humira contracts for 2023, Stewart said, though he expects the deals to be finalized by October.

“So while we will negotiate for that full year, we have to be a little cautious over the uncertainty over that many competitors in an unprecedented situation,” Stewart said. “They’re difficult negotiations. It’s certainly not easy.”