Insulin glargine (Sanofi)

“There's just too many question marks because of the complexities that we have in the U.S. market that have slowed adoption of biosimilars,” Samsung Bioepis’ head of U.S. commercial, Thomas Newcomer, said in an interview. It’s been more than 10 years since the FDA signed off on the U.S.’ first biosimilar product, opening up what was originally expected to be an easily accessible, cheaper drug market featuring heightened competition and potential new savings for patients.Now, more than 80 biosimilar approvals later, the promise of broad biosimilar adoption and lower drug prices hasn’t played out as initially anticipated, leaving the biosimilar market at a critical inflection point as it enters 2026, with policy changes and major patent cliffs creeping ever closer. 2025 was marked by “extraordinary change and progress within the biosimilar landscape,” highlighting both the opportunities and the challenges facing the field, Samsung Bioepis’ head of U.S. commercial, Thomas Newcomer, said in the company’s fourth-quarter biosimilar market report. Samsung Bioepis, which tracks the biosimilar market on a quarterly basis, found that only 73% of the U.S.’ 80 approved biosimilars launched as of September 2025. Several of the offerings awaiting a market rollout are biosimilars to Regeneron’s blockbuster Eylea, setting up a showdown in 2026 as cheaper copycats close in on the lucrative ophthalmology market.  Biosimilar beginningsThe rise of biosimilars is a relatively modern development in the history of the biopharma industry following the establishment of their regulatory pathway through the Biologics Price Competition and Innovation Act in 2010. The legislation, part of the Affordable Care Act, took inspiration from the Hatch-Waxman Act of 1984, which facilitated a booming generic drug market that today sees nearly 90% of U.S. prescriptions filled by lower-cost generics, according to the Pharmaceutical Research and Manufacturers of America.But the last 10 years of biosimilar uptake suggest the traditional market model for small-molecule generic medicines doesn’t quite fit on the biologics side, Melanie Whittington, Ph.D., head of Leerink Partners’ MEDACorp Center for Pharmacoeconomics, explained in a recent interview with Fierce Pharma. According to Whittington, research suggests that biosimilars don’t cause as rapid or as steep of a price drop for their reference products in the initial few years of market entry. Newcomer, for his part, points to an average five-year price decrease driven by biosimilars of 52% across different therapeutic areas, although uptake is “variable,” he said in an interview.Much of this variability has to do with the types of drug and the patient needs that each biosimilar product fills. For example, the adoption rate for oncology biosimilars, which may not treat patients for extended periods, is “very high,” Newcomer said. But biosimilars for chronic immunology diseases are seeing what appears to be “consistently slower uptake,” he said.It’s likely that this disparity is related to the long-term duration of therapy for chronic diseases versus treatments for cancers or other acute diseases. If a patient has had a positive experience with a brand-name drug for many years, they likely would be more hesitant to make the switch to a biosimilar. Due in part to this hesitancy and a broader lack of biosimilar awareness, “we just see patients continue on the reference product month after month, which to the patient means they could be paying hundreds to thousands of dollars more every month,” Newcomer said at an November event.Even if pricier, a positive association with a branded reference product can be a deeply entrenched dissuasion to biosimilars. In fact, Truveta Research found in June that more than 1 in 8 patients who switched to a Humira biosimilar ended up switching back to the original product. Truveta also attributes this in part to fear or uncertainty, especially for older adults whose doctors may be taking increased caution to “keep them on a treatment that’s already working well.” In any case, biosimilar and generic market entry is a concept that’s fairly unique to the biopharmaceutical industry, Whittington points out.“We don’t typically think of things that literally can substantially drop in price overnight,” she said. “And biosimilars can do that.”For patients and payers, this highlights the great promise of biosimilar drugs that challenge pricey blockbusters. When these drugs near the end of their patent protection, a line of biosimilar versions often waits in the wings to storm the market and capture a piece of the sales pie. Competition among these biosimilar offerings often comes down to interchangeability tags, pricing strategies and launch timing. Humira lessons and a Stelara futureThe first few marketed biosimilars to a major blockbuster typically reap the most rewards. Amgen, which was the first to roll out biosimilars for AbbVie’s Humira, Johnson & Johnson’s Stelara and Regeneron's Eylea, sees a major opportunity in being among the “first wave” of biosim launches, commercial head Murdo Gordon said on a February call.But if biosimilar market watchers have learned anything over the past few years, it’s that there is no one-size-fits-all handbook for biosimilar market dynamics. In the case of launch timing, some companies are “figuring out ways to make it work,” even if they launch later in the competitive sequence, Newcomer said.Biosimilar manufacturers are also adapting beyond a two-price strategy. First conceived by Biocon and Viatris for the marketing of Semglee, a biosimilar version of Sanofi’s Lantus that was the first interchangeable biosimilar, the strategy hinges on marketing both a brand-name and an unbranded biosimilar. The unbranded version is priced at a sharp discount to the reference product, while the branded offering comes at less of a discount. The idea is that the two price points can cater to different players in the healthcare system.Ultimately, in Semglee's case, the higher-priced option became more popular due to larger rebates associated with the costlier product. This strategy was widely embraced in the Humira biosimilar realm, with first-to-market Amgen kicking things off with two versions of Amjevita.However, this two-price practice may soon become a relic of the past.In the now-aging Humira biosimilar landscape, some companies have opted to discontinue their higher-priced versions, with the market showing that there “may not be a need for both versions,” Newcomer noted. Only a handful of Humira biosimilars with a higher wholesale acquisition cost (WAC) remain, while the newer collection of Stelara biosimilars includes only one contender that utilized a dual WAC in Amgen’s Wezlana.Given what is looking to be an overarching shift away from the dual-price model, it appears that the market “has decided that low WAC biosimilars are going to be the way moving forward,” Newcomer mused.This could be a result of biosimilar makers coming to the conclusion that biosimilar adoption “required much more than just cost differentiation,” Kayli Kopil, a senior market research analyst at MMIT, wrote in a July report. In response, some drugmakers abandoned the dual-price strategy and pursued market share gains by “working with pharmacy benefit managers (PBMs) rather than against them,” Kopil said. This materialized in the form of partnerships featuring private-label biosimilars.The private-label strategy, also called “white-labeling,” is already a prominent route that Stelara biosimilars have taken, as PBMs “came prepared” for the wave of Stelara copies following a “chaotic” Humira biosimilar rollout, Adam Fein, Ph.D., president of the Drug Channels Institute, wrote in a July article.PBMs utilize private labels to include their own partnered biosimilars on their formularies, a move originating with CVS Health’s biosimilar arm Cordavis in 2023. CVS linked up with Sandoz to roll out its co-labeled Humira biosimilar Hyrimoz across all its formularies, kicking off branded Humira and quickly sending Hyrimoz prescriptions skyrocketing. Today, the three major PBMs favor their own private-label Humira biosimilars and led with their private-label Stelara biosimilars as the drug’s biosimilar market opened up in 2025.  "The overall shift toward private-label biosimilars is evident,” Kopil wrote. "PBMs now hold more control than ever before in the biosimilar landscape.”To stay with the times, it may even be necessary for smaller drugmakers to seek out such PBM-manufacturer alliances to preemptively secure market positioning before committing to development, MMIT analyst Benjamin Hinton warned in a 2024 report.As for interchangeability, the competitive edge that an interchangeable label can offer is likely to wane through the FDA’s new plan to increase the availability of U.S. biosimilars. Policy reform and the biosimilar voidThrough a draft guidance document released in late October, the FDA outlined its framework to reduce clinical testing burdens for biologic drug copies and to slap an interchangeability tag on all approved biosims. As it stands, biosimilars that are deemed interchangeable may be freely swapped out in place of a brand-name product at the pharmacy counter without a doctor's approval. In its guidance, the FDA pointed out that while biologic medicines make up only 5% of the prescriptions written in the U.S., they account for 51% of the country’s drug spending.Lawmakers and advocacy groups alike have been pushing for updates to the current interchangeability structure based on concerns that the separate tags could be muddying treatment decisions and blocking biosimilar uptake. The FDA’s plan suggests that comparative efficacy studies, which are currently necessary to prove interchangeability, may be done away with in the future.This stands to cut development time and costs in half, Andrew Bourgoin of the Bourgoin Insights Group wrote in a late October All Things Biosimilar report. The FDA’s efforts coincide with a key moment for the field in the so-called “biosimilar void,” a “pressing, urgent situation that threatens the very viability of our industry,” Juliana Reed of the Biosimilars Forum pointed out in a statement last fall.Over the next 10 years, 118 biologics are expected to lose patent protection, together totaling a $232 billion opportunity for biosimilars, according to an IQVIA report. Only 12 of those 118, however, have biosimilars currently in development. The remaining 106 with no biosimilar competition on the horizon make up what has been coined the “biosimilar void.”The threat of the biosimilar void is representative of the challenges that today hinder biosimilar development. IQVIA, in its February report, listed these factors as complex regulatory requirements, slow market adoption, high investment costs, reimbursement dynamics and evolving policy creating market unpredictability.It’s for these reasons that not many companies have signed up to join the “massive opportunity” the biosimilar void presents, save for a handful of biosimilar manufacturers that are “committed to the long haul,” Newcomer said.“There's just too many question marks because of the complexities that we have in the U.S. market that have slowed adoption of biosimilars,” he explained.Meanwhile, ever-evolving policy can make hefty development costs even harder to justify. For example, mandated government pricing reductions under the Inflation Reduction Act (IRA) served as a blow to the biosimilar makers that were developing versions of some of the medicines on the list, he said.“There’s a real risk that if reference prices are capped too low, biosimilars lose their competitive edge,” William Fleming said in Samsung Bioepis’ state of the market report. Fleming, a senior advisor at Petauri Health, previously held leadership roles at Humana. As Newcomer puts it, "the question mark becomes, are you ever going to get your development costs back?” Using the biosimilar 'tool'If the first 10 years of the biosimilar market set the foundation, the next decade will be instrumental in determining its capacity for future growth, especially as closely watched patent expirations near.One key priority, Newcomer says, is building awareness. The general public is well aware of what a generic medicine is, but the same can’t be said for biosimilars. If patients knew of other, lower-cost options, broader uptake would likely follow. Especially for chronic diseases and long-term therapies, “we don’t think that conversation is taking place,” he said. Samsung Bioepis, for one, attributes its continued investment in biosimilar development to a belief that biosimilars help lower the overall cost of healthcare in the U.S., Newcomer said.“Everybody’s looking for a fix,” he said, referencing the widespread goal of “fixing” the U.S. healthcare system and pointing to pricing policies such as the IRA and, more recently, most-favored-nation drug pricing.Beyond the potential behind such policies, “we’re not using the tools that are in front of us right now,” Newcomer explained, referring to the biosimilar drug market. “We have to start using this tool.”