With its biosimilars business witnessing strong momentum, Amgen reaffirmed its confidence in the U.S. biosimilar market as the company continues to expand its leadership in this rapidly growing sector.

As the U.S. administration introduces reforms aimed at increasing the availability of biosimilars, Amgen executives expressed both optimism and caution regarding potential policy changes. The recent FDA draft guidance proposes reducing clinical testing requirements for biosimilars and classifying all approved biosimilars as “interchangeable,” in an effort to streamline market access similar to that of generic drugs.

Addressing the topic during Amgen’s third-quarter earnings call, Chairman and CEO Robert Bradway noted, “There’s an undercurrent of questioning in some quarters—particularly in Washington—about how successful the biosimilar market is in the United States. As a leading competitor, our perspective is that 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.”

While acknowledging the benefits of broader biosimilar adoption, Bradway emphasized the importance of maintaining robust regulatory standards to ensure patient safety and market integrity. “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 caused concern about its impact on patients,” he said.

Since launching its first biosimilar in 2018, Amgen’s portfolio has generated nearly $13 billion in cumulative sales, underscoring the company’s strong position in the sector. In the third quarter of 2025, Amgen’s biosimilars delivered $775 million in revenue—up 52per cent year over year—driven by the success of Pavblu, the company’s biosimilar to Regeneron and Sanofi’s Eylea, which achieved $213 million in sales during the quarter.

Murdo Gordon, Executive Vice President of Global Commercial Operations at Amgen, reiterated the company’s readiness to adapt to evolving regulatory frameworks. “I don’t think it changes our strategic focus on biosimilars. This has been a very good growth business for Amgen,” Gordon said. “Our process development and manufacturing teams continue to innovate, allowing us to remain the only company with a commercially available biosimilar to Eylea. We’re confident that we’ll remain competitive regardless of future policy changes.”

Amgen’s success in biosimilars underscores its commitment to expanding patient access to high-quality, affordable biologic therapies while sustaining innovation and excellence in manufacturing and development.