After years of legal jousting by the companies involved, the first drug has launched to challenge AbbVie’s Humira as a biological treatment for inflammatory disease.
Amgen’s Amjevita is the first in a string of nine biosimilars—closely related versions of a biologic drug that function comparably—from several firms that are becoming available in the coming year. Drug developers are watching closely: Amjevita’s sales performance in the next few months will indicate the market’s appetite for biosimilars across the US pharmaceutical industry, experts say.
“This is probably the most important biosimilar launch in the past couple of years, and probably for the next few years,” says Andrew Mulcahy, a senior economist at the nonprofit research organization RAND Corporation. “This is the drug to watch.”
Biosimilars are the biologic equivalent of generic versions of small-molecule drugs. One difference is that, like the original biologics, biosimilars are costly to develop and challenging to manufacture. Biosimilars once promised major health-care savings by introducing competition, but it hasn’t worked out that way so far.
In the case of Humira (adalimumab), AbbVie successfully set up a patent thicket around its blockbuster drug to ward off rivals from the time a key patent expired in 2016 until this year. The extended period of exclusivity has allowed the company to rake in about $20 billion in annual Humira sales for the last 5 years, making it the best-selling drug of all time.
The implications of Amjevita’s launch promise to be significant but are hard to predict, says Pamela Spicer, a principal analyst at Citeline. For example, whether Amjevita will deliver cost savings to patients is uncertain. Although Amgen offers the drug at two different discounts—5% and 55%—from Humira’s list price, the final price is unclear. It depends on the closed-door rebate offers and price negotiations between manufacturers and insurers.
The uptake of biosimilars has been “depressingly low” in the past, Mulcahy says. Amjevita could flip the script, thanks to the size of the market. The overall response to Amjevita and other Humira competitors is a bellwether for the biosimilar industry. “Is adalimumab going to be the last chapter here,” Mulcahy says, “or is it the turning point?”