The tables have turned for the U.S. biosimilars market.
With more than a decade passed since the first FDA biosim approval, strong launches of biologic copies to AbbVie’s Humira, J&J’s Stelara and Regeneron/Bayer’s Eylea are shifting a narrative once focused on lagging uptake of the category in The States.
And although the so-called biosimilar ‘void’—or the dearth of in-development products for the many branded drugs facing U.S. patent losses in the late 2020s and early 2030s—could pose challenges to upcoming biosimilar availability, the opportunity it presents is immense for developers willing to strike early and strike fast.
“We’ve been seeing the evolution, certainly since Humira went biosimilar a few years ago,” Lisa Graver, the recently installed CEO of Iceland’s Alvotech, said of the U.S. biosim scene in a recent interview with Fierce. “We’re starting to see a different uptake pattern.”
But even as regulatory and physician receptivity to the category improves, issues pertaining to reimbursement and the complex intellectual property entanglements biosimilar developers must wade through continue to put up hurdles, Graver and other industry stakeholders said in series of recent conversations on the state of the field.
A local industry finds its legs
While acknowledging biosimilar launches can be “somewhat product dependent,” especially with regard to reimbursement, Graver pointed to the launch of biosimilars to J&J’s immunology star Stelara (ustekinumab) early last year as a sign that use of the medicines is trending upward in the U.S. “The rate of uptake and adoption is much quicker,” she said.
Industry watchers have been confounded in recent years by the uneven look of the U.S. biosimilar market, which many had originally expected to take a similar trajectory to small molecule generic drugs. But that market model has apparently been a clumsy comparator, and biosimilar adoption in the U.S. has been much more variable across different therapeutic areas, experts told Fierce in a separate feature on the biosimilar industry earlier this year.
Ming Li, president of commercial operations at recent biosimilar upstart Neion Bio, echoed Graver’s enthusiasm about the uptake of biosims to Humira, Stelara and Eylea, noting that the field can’t be painted with a broad brush. Still, work remains to make the category the preferred option when prescriptions are being written, he said, calling that the “fundamental principle” that should guide legislators and regulators when drafting and implementing future policies to bolster U.S. biosimilar adoption.
Prior to his role at Neion, Li had served as chief strategy officer at Alvotech.
Reimbursement, meanwhile, also remains an area in need of improvement, in Graver’s estimation.
“But I’m optimistic, just seeing how it’s playing out,” she said, predicting that the recent momentum in the U.S. biosimilar field is “going to continue as we see solid players in the market.”
Apart from Neion and Alvotech, plus its frequent partner Teva, major outfits like Novartis spinout Sandoz, Amgen and Pfizer comprise a large chunk of the U.S. biosimilars presence.
Graver, for her part, took the reins at Reykjavik-headquartered Alvotech around the end of 2026’s first quarter, replacing founder Róbert Wessman, who had steered the company as CEO since 2023.
Under a strategic pact penned back in 2020, Alvotech and generics juggernaut Teva Pharmaceutical are attacking the U.S. biosimilar market together, wedding Alvotech’s manufacturing capabilities with Teva’s market know-how.
Alvotech’s marketed biosimilars in the U.S. include its versions of Johnson & Johnson’s Stelara (ustekinumab) and AbbVie’s Humira (adalimumab), which helped the company generate (PDF) overall product revenue of 276.4 million in 2025, up slightly from the $273.5 million it brought home for 2024.
Hacking through patent thickets
In spite of positive changes on the legislative, regulatory and awareness fronts, the patent office remains a hotly contested battleground for biosimilar developers in the U.S.
To get their biosimilars in the door, companies that look to make cheaper versions of blockbuster biologics first have to navigate waves of patents asserted by branded durgmakers. Such patent litigation often ends in a settlement that tees up the biosimilar maker to launch their offering, but typically on a delayed timeline, Tahir Amin, an intellectual property lawyer who co-founded and serves as CEO of the Initiative for Medicines, Access & Knowledge (I-MAK), explained in an interview.
With the now-infamous defense AbbVie erected around its top-selling immunology drug Humira, over 200 patents effectively prevented any copies from hitting the market for seven years after its core patent expired in 2016. In those seven years before Amgen’s biosimilar Amjevita first hit the market in 2023, AbbVie earned billions in Humira-specific revenue, suggesting that stocking up on patents “obviously pays off” for original drugmakers, Amin said.
The U.S. patent system, as Amin sees it, is currently used as a “business tool” used to block competition. The solution, he says, is a stricter standard for patents granted through the U.S. Patent and Trademark Office (USPTO).
“That's really impacting the biosimilars market, because it's costing them so much to get into the marketplace and they're often deterred, or they're going to start making choices where they're saying it's not worth our while, and that's not going to be a benefit to the U.S. consumer,” he said.
For its part, Alvotech is adopting a two-pronged strategy under Graver, which directly confronts the litigation-heavy reality of the biosimilar business.
“We look across the board at things that one: we know we can develop successfully,” she said, “and two: where we’re likely to be first—or at least if not the first, in the first wave to enter.”
Equally important to Alvotech’s strategy are products where the company can navigate the “follow-on patents” that often accompany branded biologics, with Graver admitting that the company will “take a look at where we have the opportunity to challenge the validity of a patent.” That IP strategy is “equal in importance when we talk about our development beyond the science,” the CEO said.
One ongoing patent battleground Amin pointed to, meanwhile, is Merck’s Keytruda. The deeply entrenched oncology drug’s original key U.S. patents are expected to expire in 2028, leaving a growing pipeline of Keytruda biosimiliars in development in anticipation of a “patent cliff” that year.
2028 biosimilar entry for Keytruda, however, is “wishful thinking,” Amin explained in written testimony (PDF) for a drug pricing hearing before the U.S Senate Committee on Health, Education, Labor and Pensions (HELP) committee back in 2024.
In fact, the notion of a ‘patent cliff’ in general is a “myth,” he said in his recent interview with Fierce, given “the way companies actually play the patent game.” In Merck’s case, the 2025 approval of its subcutaneous Keytruda Qlex stands to help the company prevent biosimilars for years beyond its initial patent expiry, for one.
“The fundamental problem with biosimilar competition is I think the patent system,” Amin said. “I think we would do well to start with the patent system.”
It’s a starting point that hasn’t gone unnoticed by U.S. legislators. Along with voting unanimously to advance the Biosimilar Red Tape Elimination Act, the HELP committee on June 17 agreed in a 16-6 vote to advance the Medication Affordability and Patient Integrity Act, which targets (PDF) pharmaceutical patent abuse and anti-competitive patents at the patent office.
The bill aims to end the practice of drugmakers extending their product exclusivity period by submitting partial patent information in order to facilitate subsequent patents later on, U.S. Senators Maggie Hassan (D-NH) and Josh Hawley (R-MO) explained when they introduced the bill last year. If passed, companies would be required to “certify” that they have not made “inconsistent statements” to the patent office and the FDA.
To put it a different way, companies can currently omit key technical information at the patent office until seeking to enforce additional secondary patents on different features of the drug years later.
“Big Pharma companies have been driving up their profits by gatekeeping select drug information and exploiting our bloated bureaucracy,” Hawley said in a statement at the time. “This bipartisan legislation would require manufacturers to disclose critical drug information across agencies, so Congress can finally begin to upend Big Pharma’s anticompetitive practices.”
The Senate HELP committee’s action was applauded by advocacy groups such as the Association for Affordable Medicine (AAM), which has long supported the bill.
“Greater consistency and transparency between the FDA and USPTO offers stakeholders increased certainty—and that leads to a more resilient supply chain, not only better supporting patients, but also better supporting the entire healthcare system,” AAM CEO John Murphy III commented in a recent press release from the organization.
Legislation in progress
Meanwhile, the Biosimilar Red Tape Elimination Act specifically looks to remove the currently imposed distinction between biosimilars and “interchangeable” biosimilars.
“Working to modernize the biosimilar approval framework by eliminating outdated and unnecessary statutory requirements related to interchangeability is imperative to patient access and affordable care,” Alex Keeton, executive director for the Biosimilars Council, said in the AAM release.
Biosimilar products that earn an interchangeability designation from the FDA can be freely swapped out for the pricier reference drug at the pharmacy counter, without needing the explicit go-ahead from the prescribing practitioner. In practice, that makes the process for doling out biosimilar drugs as simple as it is for small molecule generics, enabling patients and pharmacists to drive the decision.
The issue, however, is that all marketed biosimilars are, by nature, interchangeable from their reference products in clinical effect. Europe, for one, has eliminated this distinction by deeming all approved biosimilar products interchangeable. That is because, in order to win approval, the medicines must have already demonstrated that they’re “comparable to their reference products” in terms of “efficacy, safety and immunogenicity,” European Medicines Agency (EMA)’s executive director Emer Cooke said in a 2022 statement.
Neion Bio’s Li acknowledged the importance of “incentives” for biosimilar developers, such as the interchangeability designation, though he agreed that policymakers need to move beyond that perk, which he admitted had “proved not to be the carrot everyone was hoping for.”
Time-limited market exclusivity, on the other hand, of the sort that is enjoyed by generics developers who win early approvals for their products, might better tempt companies to the biosimilar market, he reckoned.
U.S. lawmakers, when crafting the biosimilar framework in the early 2000’s, opted not to outright address interchangeability in the same way that Europe has in part because the substitutable designation wasn’t as big of an issue at the time. That’s because most biosimilars, given their biologic make-up, are administered directly by healthcare providers as opposed to being picked up by patients at the pharmacy counter, Gillian Woollett, VP, head of U.S. regulatory strategy and policy at Samsung Bioepis, explained in an interview.
The challenge, Woollett said, became “misinformation” that suggested that a biosimilar without the interchangeability tag may not be the same as the reference medicine.
In a potential bright spot on that front, Alvotech’s Graver noted that she believes receptiveness among U.S. physicians has “moved well in the direction of accepting biosims as true alternatives.” The Alvotech CEO added that the advent of Humira biosimilars has gone a long way to ease initial concerns about the category, too.
The value and function of the interchangeability tag is a concern shared by the FDA as well. The agency has proposed guidance that would categorize all approved biosimilars as interchangeable and cut down on unnecessary testing requirements, with former FDA Commissioner Marty Makary, M.D., previously calling out the “serious onerous requirements the FDA has had making the process long and expensive for the makers of these biosimilar equivalents.”
To Makary’s point, Europe stays markedly ahead of the U.S. when it comes to biosimilar approvals. As of March 2026, European regulators had signed off on 168 biosimilar products, while the U.S. tally stood at 90 as of January.
U.S. market remains the prize
In Europe, the “patent games and shenanigans that play out” are far less than in the U.S., Amin told Fierce. Part of this phenomenon, beyond the differences in the U.S. and Europe’s regulatory structure, comes down to the fact that “the U.S. market is the prize,” he explained. “It’s the crown jewel for the pharmaceutical company.”
In the case of a company like Alvotech, securing a first-mover advantage is crucial, especially “in markets like the U.S., and some of the bigger markets in Europe,” Graver explained.
As for how biosimilar outfits like Alvotech are embracing the recent onshoring boom in the U.S., Graver pointed to her company’s U.S. capacity tie-up with Fujifilm Biotechnologies earlier this year, adding that onshore production is “something that is part of our strategic vision.”
Aside from appeasing requirements around U.S. trade and tariff policy, working directly with the current administration and other U.S. stakeholders could help solidify the market for Alvotech, Graver added.
“Certainly, I think there will continue to be potential for procurement opportunities, and the government is a large procurer of pharmaceuticals, so it makes sense to continue to work with stakeholders within the government on putting some preferential procurement around products that are made end-to-end in the U.S.,” she explained.
And recent policy considerations aside, the U.S. market is simply too big to ignore, with local manufacturing capacity handy either way, Graver pointed out.
“Having the end-to-end supply chain within the U.S., especially for U.S.-destined products, gives more control, gives more flexibility, you can be more adaptive to demand shifts and changes,” she said.
“We today produce out of our Reykjavik facility,” Graver explained. “Now, with the bolt-on in Fujifilm, it’s giving us a broader scope to be able to meet demand globally, but specifically for the U.S.”
Further manufacturing moves, in Europe and especially the U.S., are something that Alvotech will “continue to look to do,” Graver added.
Growing beyond big brands
Meanwhile, the prize of the U.S. biosimilar market is poised to become more tempting over the next ten years as it enters a so-called “golden decade,” which coincides with the looming “biosimilar void.” The dovetailing of the void and the golden decade present a potential $232 billion opportunity for biosimilar makers to get in on the over 100 biologic drugs that are set to lose patent protection through 2034, according to IQVIA. As of recently, only 10% of those drugs had biosimilar competition in development, however.
This, Woollett says, is “why the efficiency of development matters,” and why cutting down on the requirements for expensive comparative studies is “particularly important.”
“Nobody’s questioning do-ability. You can make biosims to any originator biologic,” Woollet said. “I think the science has asked and answered. We just have to implement more ... efficiently, such that we can rescue the void.”
Compared to generics, where cheaper copies of reference products are abundant and hold a major place on the market, biosimilars simply “cost so much more to develop,” she said.
To incentivize this costly development, “we need to create the commercial certainty that if you come up with an equivalent product at a lower price, you get market share.”
Samsung Bioepis, looking to expand its portfolio by 20 products by 2030, has unleashed a host of biosimilar products across several markets in the past few months alone, including an Eylea biosimilar in Europe following a March settlement with Regeneron and Bayer and a Stelara biosim in Japan.
This year, the company is expected to wrap up clinical studies of its potential Keytruda biosimilar following trial wins showing that the drug meets pharmacokinetic equivalence to Merck’s megablockbuster and achieved an equivalent objective response rate as well.
Meanwhile, despite increasing efforts to secure domestic supply for American-bound biosimilars, the bulk of biosimilars for the U.S. market continue to be produced abroad in countries like South Korea, India and China, as well as Europe, Alvotech’s Graver explained.
In terms of working with the present administration and other U.S. policymakers, Graver said that both her company and others should seize the moment by building sustainable infrastructure for biosimilar production in The States, echoing Woollett’s concerns about the risky expense of current studies and biosimilar infrastructures.
“I think one of the things that we’ve seen in the small molecule world is that sustainability changed over time, really resulting in a lot of offshoring,” she said. “I think biosimilars are still at that point in their lifecycle where those companies that have a robust pipeline, that are willing to enter markets first, form them early, have a real advantage from a cost basis for the U.S. patient base.”
In theory, the market for biosimilars could rival that of original products due to unequal medicine access. For any biologic on the market, there’s still “a lot of people not getting these treatments,” according to Woollett. With increased education that speaks to patients understanding the availability of cheaper options, “then there’s a lot more people available,” Woolett said. “You’ve got a much bigger market.”
Neion’s Li affirmed that high costs pinned to studies and manufacturing previously posed a significant a barrier to entry for newcomers in the U.S. biosimilar industry. But the situation has improved some in recent years, he admitted, noting that switching studies have been increasingly waved for biosimilar developers.
He wondered whether recent regulatory advances in the field might also see developers target a broader slate of development targets, rather than going after a few prize reference biologics all at once.
“The pool of targetable biologics has increased just immensely,” he said. “I think you're going to see a lot more opportunity for product selection variations between companies, and the ability to find ‘niche’ opportunities, and so I think that's a very exciting thing for the space.”