For years, industry watchers have wondered whether the U.S. biopharma business needed a jump-start as new launches languished and brands kept their dominant market positions. But Amgen’s latest quarterly results show there’s still plenty of potential for a dedicated player. Amgen’s biosimilars—a group that includes copycats to Roche cancer blockbusters Avastin and Herceptin—generated $480 million during the third quarter, the company said Wednesday. The franchise is now running at about a $2 billion-per-year rate, about double the revenue of last year, Bernstein analyst Ronny Gal pointed out on Wednesday’s call.
Despite the COVID-19 pandemic, the company has “done a really nice job …. establishing strong penetration into the U.S. oncology market,” Amgen’s executive vice president of commercial operations, Murdo Gordon, said on Wednesday’s call.
After earlier biosim launches were slow to gain steam, some experts wondered whether the U.S. would be better off giving up on the money-saving promise of biosimilars. Instead, they said, the government could regulate prices directly after biologic drugs lose exclusivity. Others, such as former FDA Commissioner Scott Gottlieb, M.D., said it was too soon to call it quits.
For his part, Gordon said it’s an “efficient market” and that “when there is a clear value on the table, healthcare systems, providers and payers are able to capitalize on it.”
“That’s what’s driving of course the uptake of our biosimilars,” he added.
Amgen’s situation is different from that of some companies marketing copycat biologics. The company has defended its own brands—such as white blood cell booster Neulasta—against biosimilar competition, and that effort has “positioned us well to understand how accounts are looking to purchase biosimilars,” Gordon said.
Further, Amgen has a “very effective provider-focused commercial presence,” the exec said, meaning the same Amgen sales reps who are discussing innovative drugs with doctors are also talking about biosimilars. The company has a patient services group that helps with reimbursement and co-pay assistance, too.
While uptake for Amgen’s oncology biosims has been stronger than the company initially expected, Gordon cautioned against making assumptions about its immunology biosimilar franchise. Amgen’s biosim to Johnson & Johnson’s Remicade has been on the market for under a year and hasn’t yet taken off. The company’s biosim to Roche’s Rituxan is set for a December decision at the FDA.
Looking forward, Bernstein’s Gal questioned whether Amgen expects to maintain its level of biosim growth next year. Gordon said the company can “continue to capture good volume albeit at some price erosion” as new competitors launch. Still, Amgen has “a lot of headroom for growth,” Gordon said.
Amgen’s results come several years after the first biosimilar launches in the U.S. Pfizer’s biosimilar to Remicade was among the early launches, hitting the market in October 2016 at a 15% discount to the brand. The copycat was slow to take off, and Pfizer sued J&J for “anticompetitive” contracting to protect its important brand. J&J hit back in a public statement that Pfizer wasn’t offering enough value to win business. This year, the lawsuit has been in the discovery process, according to law firm Goodwin.
Pfizer itself generated $424 million in sales for the biosim franchise during the third quarter. Back in August, Bernstein’s Gal wrote that the biosims market is entering a “golden age” and that the companies will generate billions of dollars in revenues from the market.
For Amgen, the biosimilar contribution helped propel the company to third-quarter revenue growth of 12% to $6.4 billion despite challenges associated with the pandemic. New immunology acquisition Otezla chipped in $538 million, while Enbrel’s quarterly haul was $1.33 billion.