As patents for some of the pharmaceutical industry’s blockbuster drugs set to expire in 2025, the market is poised for a wave of new biosimilars and generics that will create significant competition. This is the focus of Fierce Pharma’s latest annual special report, which tracks the top 10 drugs facing patent expirations and their resulting impact on the industry.
Among the major drugs featured are Johnson & Johnson’s Stelara, Regeneron’s Eylea, and Amgen’s Prolia – each set to lose U.S. exclusivity in 2025 and face off against an influx of biosimilars or generics, potentially reshaping the competitive landscape for these therapies.
Stelara: A Blockbuster Facing a Steep Decline
Johnson & Johnson’s Stelara, a widely used immunology drug, is one of the most prominent drugs in the lineup. Stelara is used to treat conditions such as psoriasis, Crohn’s disease, and ulcerative colitis, and has been a significant revenue driver for the company. However, its patent is set to expire in 2025, and it will soon face the challenge of biosimilar competition.
This year, biosimilars aiming for Stelara’s spot in the market are expected to enter, offering more affordable alternatives. The loss of exclusivity for Stelara will not only diminish J&J’s revenue from the drug, but it will also force the company to adjust its market strategy as biosimilar products carve out their share of the market.
Eylea: Regeneron’s Blockbuster Faces Generic Challenges
Regeneron’s Eylea, a leading drug for age-related macular degeneration (AMD), will also lose its U.S. patent exclusivity in 2025, opening the door for generic and biosimilar versions. With Eylea generating billions in revenue for Regeneron, the patent cliff poses a serious threat to the company’s bottom line.
As new competitors, including biosimilars, enter the market, the pricing pressure on Eylea will intensify. In particular, the launch of biosimilars could drive down the cost of treatment for AMD, but also challenge Regeneron’s established market dominance. The impact of these new entrants will likely be felt both by Regeneron and the broader ophthalmology space.
Prolia: Amgen’s Bone Drug Faces Biosimilars
Amgen’s Prolia, an osteoporosis drug, is another significant therapy nearing the end of its patent exclusivity in 2025. Prolia has long been a cornerstone of Amgen’s portfolio, providing treatment for osteoporosis and other bone-related disorders. As Prolia’s patent expires, biosimilars will enter the market, offering lower-cost alternatives.
The arrival of biosimilars in the osteoporosis space will likely cause a shift in market dynamics, with patients and healthcare providers opting for more affordable versions of the drug. For Amgen, the loss of exclusivity for Prolia represents a significant revenue loss and a reminder of the competitive pressures in the biologics market as more biosimilars come to market.
The 2025 Patent Cliff: What It Means for the Industry
Fierce Pharma’s report highlights the magnitude of the 2025 patent cliff, where multiple major biologics and medications are set to lose their U.S. exclusivity. The expiration of patents for these blockbuster drugs opens the door for biosimilars and generics to enter the market, providing more affordable alternatives for patients, but also creating a challenge for the companies that have relied on these drugs for significant revenue.
In this week’s episode of The Top Line, Fierce Pharma’s Eric Sagonowsky and Angus Liu discuss the industry implications of the 2025 patent cliff. They dive into the stories behind these 10 key drugs, offering their perspectives on the anticipated shifts in the market and the broader effects these patent expirations could have on the pharmaceutical industry.
The competition from generics and biosimilars will likely result in lower drug prices, which is generally beneficial for patients but also challenging for drug manufacturers who will need to adapt their strategies to manage revenue loss and maintain market share. As biosimilars and generics continue to gain traction, pharmaceutical companies may focus more on innovation, exploring new indications, or expanding existing drug portfolios to offset the revenue impact from patent expirations.
The industry also anticipates that patent cliffs such as these will intensify as more biologics and blockbuster drugs approach the end of their exclusivity periods. This shift marks a turning point in the industry, as the balance between protecting intellectual property and fostering competition in the healthcare market continues to evolve.
A New Era for the Pharmaceutical Industry
2025’s significant patent cliff will challenge established pharmaceutical companies to rethink their market strategies, as new entrants disrupt the landscape. With the potential for lower drug prices and increased accessibility, patients may ultimately benefit from these developments, while manufacturers will need to find ways to innovate and protect their market positions.
As we move further into 2025, all eyes will be on the evolving competition, as Stelara, Eylea, Prolia, and other blockbuster drugs face off against the growing force of biosimilars and generics. The pharmaceutical industry’s response will be critical in shaping the future of drug pricing, patient access, and innovation.