Upcoming patent losses are looming large for a number of pharma giants, including Amgen.
The company reported a strong 2024, with revenue increasing 19% from the year before to $33.4 billion and 21 products that achieved record sales for the year. But Amgen is also losing exclusivity for several key products, including its blockbusters Otezla and Enbrel, which together racked up more than $1.6 billion in 2024’s fourth quarter alone.
As it looks ahead, the company, like many across the industry, has refocused its long-term strategy to answer the question: What now?
For Amgen, the answers lie in a wide range of goals, including acquisitions, developing new products in four therapeutic areas, boosting its biosimilar business and maximizing the impact of its portfolio.
The roadmap ties to “ambitious growth aspirations over the next eight to 10 years,” according to Ian Thompson, Amgen’s senior vice president and general manager of U.S. business operations.
“We're well positioned for sustained growth in the near time and throughout 2030,” Thompson said. “We do have products … losing their exclusivity. But with the breadth of the portfolio that we have, we will continue to grow.”
Here’s a closer look at how Amgen plans to stay on the upswing.
Boosting biosimilars
Amgen is investing more in developing biosimilars than it did a decade ago.
“We're an innovative scientific company … that's the core of who we are,” Thompson said. “But we've also recognized that one of our differentiating capabilities is manufacturing large proteins, particularly monoclonal antibodies.”
Now, the company is seeing that investment pay off. Amgen said in an earnings call last month that it expects biosimilar sales to reach $4 billion by the end of the decade.
The company has already notched a win on that front this year by launching Wezlana, the biosimilar for Johnson & Johnson's powerhouse inflammatory disease drug, Stelara. It also closed out 2024 with the launch of Pavblu, a biosimilar of Regeneron’s blockbuster retinal disease injection Eylea.
Later in 2025, Amgen plans to launch Bkemv, a biosimilar to AstraZeneca's complement inhibitor, Soliris, and anticipates a phase 3 data readout in the second half of the year for a biosimilar to Bristol-Myers Squibb’s cancer immunotherapy, Opdivo.
A therapeutic focus
In R&D, Amgen is focusing on four therapeutic areas: oncology; general medicine, which includes cardiovascular, bone health and neurology; inflammation; and rare disease.
“We’ve got four large portfolios, balanced in terms of their growth performance and trajectory,” Thompson said. “All have a range of early products in the growth phase, but also some maturing products as well.”
The company is particularly excited about bispecific T-cell engagers (BiTE) like the blood cancer drug Blincyto, which picked up its third approval last year.
“We recently gained new data which brings it into the consolidation phase of acute lymphoblastic [leukemia], and also pediatric phase as well, so we’re able to treat a lot earlier now for small tumors in that space. That’s driving considerable expansion, treating more patients,” he said.
He also pointed to the potential of Imdelltra, which nabbed FDA approval for small cell lung cancer last year for second-line plus patients.
“We have ongoing studies there to bring it into earlier lines as well,” Thompson said. “It’s having a dramatic impact in a disease that was previously very difficult to treat.”
Amgen’s moves in the rare disease space have been buoyed by its 2023 acquisition of Horizon Therapeutics, which Thompson said gave the company the opportunity to take their treatments into international markets. For example, the company launched Tepezza in Japan and is filing for regulatory approval in other markets, too.
“We see that path unfolding for other assets like Krystexxa,” he said of the company’s treatment for chronic gout.
Amgen is also looking to expand the reach of its drug Uplinza, which is currently approved for a rare autoimmune disorder.
“Uplizna’s very exciting, we’re got a couple of new indications coming through on that,” Thompson said.
In the cardiovascular and inflammatory spaces, Thompson highlighted the company’s optimism for olpasiran, a small interfering RNA drug designed to reduce lipoprotein(a) in late-stage development, and Tezspire, which is approved for severe uncontrolled asthma and has shown phase 2 promise for COPD.
And like many companies, Amgen is playing its hand in the obesity space. Its GLP-1 candidate, MariTide, which it is developing to go up against competition like Ozempic, reported an average weight loss of up to 20% at week 52 without a weight loss plateau in a phase 2 study.
“Whilst there are two companies in the market today, there appears to be plenty of room for treatment options that are differentiated, whether that’s through a differentiated weight loss profile or a differentiated dosing profile or the ability to treat other disorders,” he said.
