Aflibercept

The end of the U.S. patent runway is nearing for 10 industry blockbusters in 2025. While each year features high-profile losses of exclusivity in the pharma industry, this year's list is something of a doozy.For one, Johnson & Johnson's Stelara is already facing off against several biosimilars, and several more are yet to come as the year plays out. With $6.72 billion in U.S. sales in 2024, the drug is the largest U.S. loss of exclusivity since AbbVie's megablockbuster Humira tumbled over the patent cliff in early 2023. Johnson & Johnson had previously warned of a "late 2023" patent cliff for Stelara, but the company was able to squeeze more life out of its key immunology moneymaker through a series of legal settlements.Johnson & Johnson's not alone in losing U.S. market exclusivity on a key sales driver this year. Also facing ongoing or future declines for their top revenue generators are Regeneron with eye drug Eylea, Amgen with bone medicines Prolia/Xgeva and Novartis with heart failure therapy Entresto. Eylea already faces its first U.S. biosimilar after Amgen launched Pavblu in November. Fierce Pharma chose to include Eylea in this report—despite the biosimilar launch happening last year—because the commercial situation is still playing out for Regeneron and to not exclude a key development in an important market.Amgen, for its part, collected $4.39 billion in revenue from its key bone medicines Prolia and Xgeva last year. While the company has built its own impressive biosimilar business over the years, it'll have to play an unfamiliar role and watch copycat drugs eat away at the market for its originators starting in late May and early June.Novartis, meanwhile, has warned of a "mid-2025" loss of U.S. exclusivity for Entresto as a key combination patent nears its expiration this summer. Besides Entresto, Novartis has two other big-selling products on this list in Promacta and Tasigna.Moving down the list, readers will likely notice two high-profile drugs from AstraZeneca. Rare disease medicine Soliris, picked up in AZ's buyout of Alexion, is set to face its first biosimilar from Amgen sometime in the second quarter. And Brilinta, a cardiometabolic drug once pegged to be a key blockbuster but that never quite met expectations, is also running out of its U.S. patent protections in the near future.For one measure of the high-profile nature of the drugs on this list, look no further than last year's version of the report. With $1.45 billion in prior-year U.S. sales, Bristol Myers Squibb's Sprycel led the 2024 group. But, if compared against the 2025 class of patent expirations, Sprycel would rank No. 6. There are always uncertainties in compiling this report due to the unpredictable nature of patent litigation and regulatory interactions. This year, the drug with the most apparent uncertainty is J&J's Simponi and Simponi ARIA. That medicine's inclusion hinges on a potential fourth-quarter approval—and launch—of Teva and Alvotech's AVT05. We opted to include the medicine because a key patent has already expired, and a reputable biosimilar team is marching through the regulatory process.To compile this report, Fierce Pharma parsed company filings, presentations and conference call transcripts. We also used published research from pharmacy benefit manager OptumRx and healthcare services firm Cardinal Health. The report ranks the top U.S. losses of exclusivity based on U.S. sales from the prior year.

The US Court of Appeals for the Federal Circuit on Friday ruled against Regeneron in a closely-watched patent infringement case involving the New York biotech’s blockbuster eye drug Eylea and Amgen’s competing biosimilar Pavblu, which launched last November. Regeneron did not establish “a likelihood of success on the merits of its infringement allegations and the district court did not abuse its discretion in denying its motion for a preliminary injunction,” Circuit Judge Alan Lourie wrote in his opinion on Friday . The appeals court loss for Regeneron follows a similar district court loss late last year that enabled Amgen to launch Pavblu as the first Eylea biosimilar in the US, after it won FDA approval in August 2024. Regeneron has recently looked to shift the market from Eylea to its higher-dose version, which first won FDA approval in August 2023 for wet age-related macular degeneration, diabetic macular edema and diabetic retinopathy, as biosimilars to the biologic were emerging. Regeneron told Endpoints News in an emailed statement: “Regeneron has invested many years of effort into its design and development of EYLEA (aflibercept) Injection 2 mg. This work has resulted in numerous patents, reflecting our important research and innovation. We continue to believe that Amgen is infringing our patent rights, and we look forward to presenting our case at trial.” Regarding uptake of Amgen’s Pavblu so far, Regeneron EVP Marion McCourt said at a TD Cowen conference earlier this month that it’s “been limited.” TD Cowen’s Tyler Van Buren noted that Wall Street consensus for Eylea 2 mg “has come down with the introduction of Pavblu. I think for this year, 2 mg is maybe down like 15%, if not 20% year-over-year.” McCourt added, “We’ve got a really busy year in terms of increments to the label, delivery system, more clinical data. It really is an exciting time for the launch of EYLEA HD.” In addition to Pavblu, the FDA in 2024 approved four other Eylea biosimilars — Biocon Biologics’ Yesafili, Sandoz’s Enzeevu, Formycon’s Ahzantive, and Samsung Bioepis and Biogen’s Opuviz. Because of remaining patents for Eylea, analysts have said they don’t expect other biosimilars to launch until 2027.