With its biosimilars business thriving, Amgen is in a unique position to comment on U.S. biosimilar policy as the current administration introduces reforms to increase the availability of the copycat drugs. As officials discuss easing biosim regulatory standards, Amgen execs shared a word of caution—and also optimism about being able to adapt.
In draft guidance released last week, the FDA laid out a plan to reduce clinical testing burdens for biosimilars and to categorize all approved biosimilars as “interchangeable.” In announcing their effort, RFK Jr. and FDA Commissioner Marty Makary, M.D., said they wanted to make it easier for companies to bring biosimilars to the market, much in the way that generic drugs are regulated.
“There’s an undercurrent of questioning in some quarters—particularly in Washington—about how successful the biosimilar market is in the United States,” Amgen CEO Robert Bradway said during the company’s third-quarter call. “As a leading competitor, our perspective is the market is performing very well. We think the ground is well set for this to continue to be a flourishing market in the U.S.”
To establish the need for reform, RFK Jr. and Makary pointed out last week that European regulators have approved twice as many biosimilars as U.S. regulators have. Amgen believes, however, that relaxing standards to get more knockoffs on the market could be problematic.
“We watch carefully to make sure that policies don’t emerge that might move this marketplace in the direction of the generic drug industry where there have been a number of abuses that have given rise to quite a bit of anxiety about that market and its impact on patients,” Bradway added.
Adding biosimilars to its portfolio has worked out well for Amgen. Since the business gained its first approval in 2018, the copycats have generated nearly $13 billion, the company said Tuesday.
In the third quarter, biosimilars accounted for $775 million in sales for Amgen, which were up 52% year over year. Pavblu, which is the company’s knockoff of Regeneron and Sanofi’s Eylea, pulled in sales of $213 million in the quarter.
If the biosimilars business landscape changes in the U.S., Amgen will be in position to adjust, Murdo Gordon, the company’s executive vice president of global commercial operations, said.
“I don’t think it changes our strategic focus on biosimilars. This has been a very good growth business for Amgen,” Gordon said. “We’ve got a great process development team here in our manufacturing operations organization who continue to do very innovative things in the development of biosimilars, such as helping us be the only biosimilar to Eylea commercially available on the market. We think we’ll be in good shape. We’ll be competitive no matter what the guidelines.”
Amgen had a banner quarter, blowing away expectations behind sales of Repatha—which were up 40% to $794 million—and Prolia, which came in at $1.1 billion, beating expected sales of $944 million.
As for Repatha, company executives gushed about trial results that will be revealed this weekend at the 2025 American Heart Association Scientific Sessions in New Orleans. Last month, the company said a study showed Repatha significantly curbed the risk of major adverse cardiovascular events over standard of care treatment alone in people who hadn’t had a heart attack or stroke.
“I think the word ‘landmark’ gets thrown around a lot in describing clinical trials, but I don’t think it’s an inappropriate moniker to put on this one,” Gordon said. “I think this is a substantial advance in understanding how you can prevent first heart attacks and strokes. This is a call to action for primary care physicians everywhere.”
For the quarter, Amgen reported sales of $9.6 billion, which was a 12% increase year over year. With the result, Amgen increased its 2025 revenue projection to between $35.8 billion and $36.6 billion, up from a range of $35 billion to $36 billion three months ago.
Editor's note: This story was updated to properly reflect the nature of the comments from Amgen executives.