Amgen's hyped Humira biosimilar fritters away its exclusivity advantage

In January, when Amgen launched the first biosimilar to compete with AbbVie’s Humira in the U.S., the company looked forward to six months of exclusivity in competing one-on-one against the immunology powerhouse.

How’s it going lately? Not so well.

Amgen has reported second-quarter U.S. sales of Amjevita at a mere $19 million, a 63% drop from $51 million it generated in the first quarter.

Why has such a hyped product delivered so little?

“We’re obviously very early in this biosimilar market with Amjevita and we’re seeing clearly new payer behavior in light of such a large product having biosimilar competition,” Murdo Gordon, Amgen’s chief of global commercial operations, said on a conference call.

Gordon also chalked up the sales decline to “inventory drawdown after stocking to support the launch in the first quarter.”

In launching Amjevita in the U.S., the company applied what seemed an unusual strategy, making it available at two price points—one at 55% below Humira’s list price and another at 5% below. At the time, Humira was priced at $6,922 per month before any discounts.

While the 55% discount looked good on paper, the expensively priced Amjevita has been favored by pharmacy benefit managers (PBMs), Amgen said Thursday.

The reason, of course, is rebate dynamics, which helps explain why the uptake of biosimilars has been hindered in the U.S. and why some in Congress are pushing for PBM reform.

Amgen believes that as several other Humira biosimilars launch this summer, the market will start to take shape.

“The product mix, I don’t think, has settled out yet,” Gordon said. “I would also say that we’re still waiting to see what happens in the next payer negotiation cycle, going into 2024. Many of the PBMs are on record saying they haven’t done a whole lot in terms of driving utilization of biosimilars but plan to do more of that in 2024.”

As for AbbVie, the company recently said its Humira patent cliff year is playing out about as well as could be expected for the branded drug. The company now expects Humira’s sales erosion to come out to 35% this year, compared with a prior estimate of 37%.

“We are competing very effectively with the various biosimilar offerings," AbbVie CEO Richard Gonzalez said during a conference call last month.

Meanwhile, outside of the U.S., Amgen’s sales of its Humira biosimilar continue to climb, reaching $131 million for the second quarter, a 29% year-over-year increase.

Overall, Amgen reported global revenue of $7 billion, its most ever in a quarter, the company said. The result topped the analyst consensus of $6.66 billion and was a 6% bump year over year.

As a result, the company lifted and narrowed its revenue projection for the year to a window of $26.6 billion to $27.4 billion. That estimate does not include any expected contribution from the company’s $28.3 billion acquisition of Horizon, which Amgen expects to complete by the end of the year, CEO Robert Bradway said.

Amgen’s top products performed well in the quarter, with cholesterol treatment Repatha delivering a 30% year-over-year jump to $424 million. Sales of osteoporosis drug Prolia increased 11% to $1.03 billion, while Enbrel generated revenue of $1.06 billion, good for for a 2% bump.

New cancer drug Lumakras, which is considered one of Amgen’s hottest properties, continued to disappoint as sales remained flat at $77 million. The company said 20% volume growth was offset by lower net selling price and inventory levels.