While the FDA is making it easier to regulate copycat versions of expensive drugs that millions of people take for arthritis, cancer and other ailments, the U.S. patent office is making it harder for cheaper drugs to get to market, industry officials say.
Those officials were delighted Oct. 29 when FDA Commissioner Marty Makary announced the agency's plan, which he said would cut in half the time and money needed to bring so-called “biosimilar” drugs to market. Biosimilars are essentially generic versions of biologic drugs like Humira, Keytruda, and Xolair that are made from living organisms. Biosimilars can cost up to 90% less.
Under the guidelines proposed by the FDA, the agency would begin to regulate biosimilars in a similar way to how it regulates generic drugs, which are copies of simpler molecules, usually tablets. This change in approach could allow companies to save up to $100 million on each drug they develop, allowing them to produce more products for underserved patients, said Stefan Glombica, CEO of Formycon AG, a biosimilar maker based in Germany.
But President Donald Trump's patent office is working at cross purposes with the FDA, biosimilar makers say, narrowing the options for companies that try to challenge the raft of patents that brand-name drugmakers file to protect their products from competition.
In the past, biosimilar manufacturers were able to invalidate some of these patents through an expedited procedure called “inter partes review,” or IPR. But the new administration rejected most of the intellectual property requests and released proposed rule in October, making it difficult to obtain intellectual property rights.
Heavyweights in pricing
Biosimilars have the potential to reduce or even eliminate major healthcare costs in the United States. Only 5% of prescriptions are for biologics, but they account for more than half of prescriptions. $600 billion the country spends annually on medicines.
“Generic and biosimilar competition is a critical way to lower prescription drug prices,” said William Feldman, a pharmaceutical policy researcher at the University of California, Los Angeles.
The FDA's announcement “is good and may ease barriers,” he added, “but there are a lot of caveats.”
In fact, according to the biosimilars industry, FDA regulation is often the least of the three major obstacles they face in marketing their products.
To protect their market share, manufacturers of brand-name biologics file numerous patents or even hundreds of patents, continuing to do so long after their drugs are on the market. The “patent dance” that occurs when biosimilar manufacturers seek to bring competing drugs to market can drag on for many years.
For example, the FDA approved the first biosimilar of the rheumatoid arthritis drug Humira in 2016, but legal battles delayed competitors' entry to market until there were nine FDA-approved products. launched in 2023. In his Press conference October 29.Makary blamed FDA “bureaucratic red tape” for the delay, but industry officials said it was largely due to an unclear patent mechanism.
The new rules, which could go into effect next year, would formalize recent FDA practices aimed at speeding up the approval process for biosimilars. For example, the FDA recently allowed drug makers to opt out of the costly clinical trials required by the 2009 law. The agency now allows companies to use less expensive analytical tests if they can show that the biosimilar is not clinically meaningfully different from the brand-name drug.
The burden of “switching”
Because biologics are large molecules derived from living cells, their copies cannot be chemically identical. Therefore, the FDA has required that biosimilars undergo clinical studies similar to those required for brand-name drugs. But studies have shown that analytical methods can replace the need to test biosimilars on large numbers of patients.
The new rules will also confirm the FDA's waiver of requiring so-called “switch” tests, in which patients first take a brand-name drug and then a biosimilar, or vice versa, to see if their responses match. Such tests are required in many states for a biosimilar to receive “interchangeable” status, which allows pharmacists to substitute an often cheaper version of a prescribed brand-name drug.
In short, the new rules will mean biosimilar makers will spend less money getting drugs to market, says Sean Tu, a law professor at the University of Alabama. “What this won’t do is allow you to get to market sooner,” he added.
Once launched, biosimilars can take years to gain a foothold in the market. Humira biosimilars had little impact on the market in 2023, and accounted for only about a quarter of sales in 2024, although they cost just 10% of the brand-name drug's monthly price of about $6,500.
That's because big-name drug companies offer lucrative discounts for selling their drugs to middlemen who create formularies—tiered lists that tell doctors and pharmacies which drugs are covered by insurance. These intermediaries, pharmacy benefit managers, pass on some of that money to health plans.
Essentially, insurance plans “charge higher costs to people who require expensive drugs as a way to subsidize the entire population,” said Wayne Winegarden, an economist at the Pacific Research Institute.
The patent thickets are thickening
Biosimilar makers are particularly concerned about the direction the U.S. Patent and Trademark Office has taken under Trump.
Patent litigation is already 10 to 20 times more expensive in the US than in Europe, and limiting inter partes proceedings only makes the situation worse, says Formycon's Glombica.
The FDA recently allowed his company to forgo costly clinical trials of its biosimilar substitute for Keytruda, a popular cancer drug. But Merck & Co., which got about half of its $17 billion in third-quarter revenue from Keytruda, is expected to fight tooth and nail to protect its many patents on the drug. The Trump administration's new obstacles to challenging them “counteracts failure,” Glombica said.
Merck defends its innovations, said spokeswoman Julie Marie Cunningham. However, while noting that Merck is promoting a new injectable form of Keytruda, she said the company does not expect it to affect “potential marketing” of biosimilars of the older, intravenous form of the drug.
The Pharmaceutical Research and Manufacturers of America, or PhRMA, an industry group representing most major brand companies, “welcomes the administration's focus on increasing access to and affordability of biosimilars,” spokesman Alex Schriver said.
But big pharmaceutical companies are applauding the patent office's attempt to strengthen protections for filed patents, according to attorneys involved in intellectual property litigation.
“I don’t think the Trump administration has a coherent plan here,” said Mark Lemley, director of the Stanford Program in Law, Science and Technology. While Trump officials want to lower drug costs, “they also want to make it more expensive to figure out whether patents are valid by effectively eliminating intellectual property rights,” he said.
The patent office did not respond to repeated phone calls and emails.
Patents and patent litigation are the biggest barriers to bringing biosimilars to market, said UCLA's Feldman.
For example, in 2016, the FDA licensed a biosimilar of Sandoz's Enbrel, a popular drug for treating autoimmune diseases, but Sandoz won't be able to sell its competitor in the U.S. until 2029 at the earliest due to patent issues. Without insurance, Enbrel costs between $7,000 and $9,000 per month.
Patient's view
Judy Aiken, a retired nurse from Portland, Maine, who has been taking Enbrel since 2007 to treat psoriatic arthritis, would be interested in trying a copycat if it cost her less. Since retiring in 2019 and switching to Medicare, she spends thousands of dollars annually on medications.
The Biden-era Inflation Relief Act capped her out-of-pocket drug costs at $2,000 this year, and Aiken and her husband used the savings to replace the roof and furnace. But with health care changes on the horizon, “now I'm afraid the other shoe will drop,” she said.
Only about 10% of the 118 biologics slated to go off patent in the next decade have biosimilars in development, reflecting weak incentives in a system that biosimilar makers and patient advocates say is rigged against them.
But lower costs could allow companies like Formycon to expand their product lines currently focused on cancer and autoimmune diseases to less common or even rare diseases, said CEO Glombica.
“People have been talking about the promise of biosimilars to cut costs and give consumers more choice, and I feel like we're still waiting,” said Anna Hyde, director of advocacy and access for the Arthritis Foundation, which lobbies for research and treatments.
While biosimilars can save everyone money, patients typically don't care whether they get them or not, Hyde noted. Some are reluctant to switch once they have found a brand-name drug that works for them, as the search can be overwhelming for people with autoimmune diseases, she said.
“Usually they can’t access them anyway,” she said, “because they’re not on the form.”
