Image above from a recent Humira ad.
The Humira wars have begun, as the first branded biosimilar to break Abbvie’s 20-year exclusivity on the top-selling anti-inflammatory drug has launched, cutting into what the New York Times called “the most lucrative franchise in pharmaceutical history.”
Amgen’s Tuesday morning debut of Amjevita, its nearly identical drug to Humira (used to treat rheumatoid arthritis and other autoimmune conditions), overshadowed its fourth quarter, full-2022 earnings and 2023 guidance released later in the day.
Indeed, the new biosimilar ‘s entry in the marketplace will likely have a greater future impact on Abbvie’s fortunes than on Amgen’s.
Wall Street analysts have been predicting a 10% drop in Abbvie’s revenues for 2023, according to TheStreet.com.
Abbvie won’t announce its fourth-quarter 2022 earnings until Feb. 9, but in the third quarter Humira sales had totaled $5.6 billion, about 38% of the company’s total revenues of $14.8 billion.
And Amjevita isn’t the only Humira biosimilar coming to the U.S. market. With Abbvie’s patent on the drug expiring, up to nine more Humira biosimilars plan to be in the market by this summer. They include entries from Pfizer, Merck, Boehringer Ingelheim and Sandoz.
Amgen’s Amjavita has already been available outside the U.S, where it had net sales of $119 million in the fourth quarter, up 3% year-over-year from $115 million. For the full year, sales rose 5%.
During an earnings call with analysts, Bob Bradway, Amgen chairman and CEO, said that Amjevita and other biosimilars (Amgen has six more planned for the rest of this decade) “will contribute to our growth over time” and Murdo Gordon, executive vice president of Global Commercial Operations, said Amgen expects a “gradual uptake” of the new product in the coming months. On day one, he added, Amgen was already receiving “inbound interest from peers, prescribers and patients.”
Abbvie, meanwhile, has been preparing for the loss of its Humira exclusivity for a while. During the firm’s third quarter earnings call in October, chairman and chief executive officer Rick Gonzalez said the company expected Humira sales erosion of about 45% in 2023 due to the launch of Amgen’s Amjevita and other biosimilars coming in the U.S.
One of the key factors in that forecast, Gonzalez said, would be pricing of the biosimilars.
On that front, Amgen on Tuesday announced two Amjevita list prices -- 55% less than Humira, and 5% less than Humira.
Responding to a question from Chris Raymond of Piper Sandler about this dual pricing, Bradway said the approach stems from the “complexity” of the U.S. market.
The business model of pharmacy benefit managers, he said, “requires that they negotiate rebates with manufacturers. So they would prefer a high list price, and negotiate rebates to net the price down and then pass those rebates through to their clients.”
Gordon also noted that Amgen is “providing financial assistance support and reimbursement support for both prescribers and patients to launch the product.”
The New York Times, which described Abbvie's 20-year monopoly on Humira-like drugs as a "gaming of the U.S. patent system," reported that Abbvie had increased Humira’s price 30 times since its launch -- including an 8% hike just this month.
Even as sales move to biosimilars, Abbvie will receive an unidentified royalty from each purchase.