In the pharma world, January 31 marks an important anniversary: the day the first biosimilar of Humira, the best-selling drug in the world, hit the market.
Humira, which enjoyed market exclusivity for 20 years until its patent expired at the beginning of 2023, raked in $21.2 billion for drugmaker AbbVie in 2022 and roughly $200 billion since it first came to market. Biosimilars are lower-cost alternatives with the same effect as the original drug, but could save patients—and the healthcare system—a lot of money.
“Biosimilars have the potential to lower spending on biologic drugs that account for a rapidly increasing share of overall US prescription drug spending,” Andrew Mulcahy, a senior policy researcher at nonprofit research organization Rand, said in a statement.
Today there are nine Humira biosimilars on the market from big-name drugmakers like Pfizer and Novartis as well as smaller companies like California-based Coherus. The drugs are designed to treat inflammatory conditions like rheumatoid arthritis and Crohn’s disease.
How the biosimilars have fared against Humira
The first biosimilar, Amgen’s Amjevita, got an advantage: six months of market exclusivity. The other eight biosimilars then came on the market in July 2023.
AbbVie braced for a big hit to Humira sales when the biosimilars hit the market, projecting the company would lose up to $7.9 billion.
But so far, the biosimilars haven’t put up much of a fight.
In October 2023, Amgen reported just $23 million in sales for Amjevita after the drug had been on the market for nine months.
Organon, a New Jersey-based drugmaker that makes the biosimilar Hadlima, lowered its full-year guidance for 2023 last September, citing in part a slow uptake of the biosimilar. The company reported just $2 million in sales for the drug, which had been on the market for roughly three months at the time.
Coherus reported $1.4 million sales of its biosimilar, Yusimry, in its most recent earnings released in November 2023.
In comparison, AbbVie reported $3 billion in US Humira sales in Q3 2023 alone and $9.4 billion for the first three quarters of the year in its most recent earnings report released in October 2023. For the first nine months of 2023, Humira sales fell 30.8% compared to 2022, a less severe drop than the anticipated 37%, though full-year results have yet to be reported.
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AbbVie is also still dominating the weekly average number of prescriptions, recording roughly 76,000 Humira prescriptions written per week in the second half of 2023. Amjevita, which is in second place, averaged just 417 prescriptions per week, according to data from life sciences research and analytics firm Iqvia.
“The dismal uptake and access for the Humira adalimumab biosimilars are staggering,” Juliana Reed, executive director of the Biosimilars Forum, a nonprofit meant to increase biosimilar uptake, said in a statement.
Fewer than 1,000 of the 42,000 eligible patients received access to a biosimilar as of November 2023, according to Reed, who added that Medicare Part D has the lowest biosimilar utilization.
The biosimilars also have yet to be very effective at lowering overall healthcare costs.
Amejvita, the best-selling biosimilar, has two different price points: one that’s 55% cheaper than Humira’s roughly $7,000 monthly list price and one that’s just 5% cheaper. The version that’s 5% less expensive than Humira has sold better than the cheaper version because Amgen gives pharmacy benefit managers and payers larger rebates on it than the lower-cost version, Forbes reported.
Physicians hesitant to make the switch
Ultimately, payers and physicians bear the responsibility of diverting patients away from Humira to the lower-cost biosimilars, according to the American Journal of Managed Care.
But many physicians have been hesitant to switch patients to a biosimilar, according to a report from life sciences market research firm Spherix Global Insights, which found that dermatologists have been the most reluctant to prescribe a Humira biosimilar.
“This current reality is unacceptable. Patients must be able to fully access FDA-approved, lower-cost biosimilars,” Reed said in a statement. “When formularies, especially Medicare formularies, prioritize high-cost, high-rebate products, patients suffer. Lawmakers on the Hill must intervene to deliver on policies that provide more affordable biosimilars to those who need them so that we can continue to deliver on our commitment to bring competition and lower-cost biosimilars to patients.”