Biosimilars Forum Chafes at the Humira Bit

When AbbVie negotiated with biosimilar companies for a share of its lucrative Humira (adaliumumab) franchise, it was handled much like a family court proceeding, with separate secret contracts being drawn up for each biosimilar company.

But a year after biosimilar competition began, AbbVie retains the lion's share of the Humira market, and biosimilar companies are looking unsmilingly at the small pile of chips on their side of the card table.

Samsung Bioepis, in its assessment of biosimilar adalimumab progress at year's end, said biosimilar companies had carved out just a 2% share of the market.

Meanwhile, the Biosimilars Forum, an industry association of biosimilar makers, is calling once again for legislative and government policy fixes that will enable biosimilars to go where they don't appear to be able to go by themselves, lower costs notwithstanding.

Juliana M. Reed, M.S.

“The dismal uptake and access for the Humira adalimumab biosimilars are staggering,” wrote Juliana M. Reed, M.S., executive director of the Biosimilars Forum and a former Pfizer vice president of corporate affairs.

“Out of 42,000 potential patients, less than 1,000 have received access to an adalimumab biosimilar,” Reed said in November, when eight Humira biosimilars were on the market and another, Pfizer’s, was just launching.

To be sure, not all adalimumab biosimilars are created equal. Some are high concentration, some are low concentration; some are latex free or citrate free; and a couple are “interchangeable” with Humira, a designation that means pharmacists can freely substitute them for Humira without prescribing physicians’ approval, although state pharmacy laws can also come into plays

Biosimilars do tend to ramp up over time and capture significant market share from brand name reference product. But that takes about three years, not just one, Samsung Bioepis noted in its report.

Still, that isn't enough for the Biosimilars Forum, which is fully aware that with each year that goes by — perhaps each month — AbbVie succeeds in tilting more prescriptions away from Humira and toward its next generation anti-inflammatory products, Skyrizi (risankizumab) and Rinvoq (upadacitinib).

That's bad news for the Biosimilars Forum. It means the Humira market overall is shrinking, and biosimilar companies will have to run harder to stay in the same place, market share–wise.

AbbVie is predicting these two products will soar in combined sales revenue from $11 billion in 2024 to $27 billion in 2027 — far more than Humira could do by itself.

There is potential help on the way for the Biosimilars Forum—and for patients who are hopeful for lower cost biologics.

In 2023, the Health and Human Services' Office of Inspector General noted that biologics spending in Medicare Part B alone could have been reduced by $419 million or 9% in 2021 if biosimilars had been substituted for originator products. The office recommended legislation to make this happen.

Under Part D, upwards of $12 billion is spent on biologics each year, according the Office of Inspector General.

Related to that, the Senate Finance Committee has released draft legislation that would compel Medicare Advantage and Medicare prescription drug programs to put high-discount Part D biosimilars on formulary, if available, at equal or favorable cost-sharing and prescription management terms to originator biologics. The draft legislation defines high discount biosimilars as being priced 45% less than the wholesale acquisition cost for originator drugs.

In other good news for biosimilars, CVS recently announced it is dropping Humira from its formulary in favor of biosimilars.

For the Biosimilars Forum, these things should help get the party started, although the draft legislation would not go into effect before 2026.