The Biosimilars Report Card

tt was supposed to be the start of a new era of competition and cost reduction in one small but increasingly important corner of U.S. healthcare. On March 6, 2015, the FDA approved the first biosimilar, Zarxio (filgrastim-sndz), a copy of Neupogen (filgrastim), a mainstay for treating neutropenia and boosting infection-fighting white blood cells. Biosimilars were supposed to do for high-priced biologics what generics did for small-molecule drugs, sweeping aside expensive brand-name products for cheaper facsimiles that were just as effective. In the long, running battle to rein in U.S. healthcare costs, generics for small-molecule drugs stood out as one of the few clear victories.

Now, a decade later, there’s a range of opinions on whether biosimilars and the market for them have lived up to their promise. In some cases, they have largely supplanted the brand-name products as lower-priced alternatives, especially when the biologics are infused and paid for on the medical side of people’s health benefits or, in the case of Medicare, under Part B. In others, adoption has been low, partly because brand-name manufacturers have discounted their products or launched new brand-name products that end up stifling demands for biosimilars. And for biosimilars paid for through pharmacy benefits, the power of the “big 3” pharmacy benefit managers (PBMs) — CVS Caremark, Optum Rx
and Express Scripts — to dominate the market has been evident as they have struck deals with biosimilar manufacturers to be the exclusive distributor for their products or to comarket biosimilars in a house brand-type arrangement.

Thomas Newcomer,MBA

Thomas Newcomer, MBA, says biosimilars have yielded $36 billion in savings so far for the U.S. healthcare system.

“So from that standpoint, have they made a difference? Absolutely. Have they made a difference to the level where we would expect? I would say no. There’s still a huge opportunity in the United States for these products,” says Newcomer, the vice president and head of U.S. commercial operations and market access for Samsung Bioepis, one of the major biosimilar manufacturers.

Even if biosimilars do grade out as bona fide cost cutters, some industry observers see troubled waters — uneven adoption, pricing trends that squeeze profit margins to a sliver, unanswered questions about the viability of the markets for biosimilars for rare diseases.

Craig Burton, MBA

Asked to grade the biosimilars market, Craig Burton, MBA, executive director of the Biosimilars Council, a trade group for the industry, gives it an incomplete. “It is delivering on the promise of lower prices. It is delivering on the promise of expanded access. It is not today a healthy market. It is not a market that is sustainable in the long run.”

The health of that market will be tested in 2025. In the short history of biosimilars, 2023 stood out as a zenith year because a burst of biosimilars, including Humira (adalimumab), one of the top-selling drugs of all time, came on the market, with nine that year followed by a 10th, Simlandi (adalimumab-ryvk), early in 2024. But the Humira biosimilars were slow to catch up, partly because of moves by Humira’s maker, AbbVie. Now another surge of biosimilars might happen as seven biosimilars to top-selling Stelara (ustekinumab) are poised to come on the market this year, although Burton points out that a quirk in the Inflation Reduction Act (IRA) of 2022 may lead to marketing strategies that delay launches. Meanwhile, Samsung Bioepis and Amgen are gearing up to launch biosimilars to Soliris (eculizumab), a drug that treats a pair of rare blood diseases. Newcomer says the biosimilars for Soliris and other biologics for rare diseases may be a throwback to the days when adoption hinged on persuading clinicians that biosimilars were similar to the point of being clinically indistinguishable from the reference product.

“Biosimilars are going to be brand-new for a lot of these specialists,” says Newcomer. “We may be going back to a point in time where you are showing the equivalency of a biosimilar to an originator molecule, because these [biosimilars] are new for this specific specialty.”

Held back

Samsung Bioepis issues quarterly reports on the status of the biosimilar market, and the report for the first quarter of 2025 listed 64 approved biosimilars as of December 31, 2024, of which 41 (64%) had launched. At press time, the FDA had approved three more biosimilars in 2025, two for Prolia (denosumab) and Xgeva (denosumab) and another for NovoLog (insulin aspart). Pointing to the 64 approvals through 2024 across 13 different molecules, Steven Lucio, Pharm.D., says, “If you had asked me back in 2013, I would have said, ‘Oh my gosh, that is the best news ever.’”

Lucio, principal at Vizient, a group purchasing organization, says opinions about biosimilars have been formed by unrealistic expectations that the market for them would behave like the market for generics for the small molecules. Everything about biologics is more complicated, Lucio says, from the supply chain to their administration to how they are paid for. “We don’t see, by and large, the shift in market share where the competition takes over,” Lucio observes. Part of it is just the landscape for high-cost medications is different, he adds. “I understand people’s frustration, but I think we’re still on a good journey.”

The Samsung Bioepis report paints a mixed picture. Overall, biosimilars have gained, on average, a 53% market share within five years after the first one was launched. But that average obscures some wide, molecule by molecule, variation. While four biosimilars to Avastin (bevacizumab) have gained 89% of market share six years after the first one launched and the five biosimilars to Herceptin (trastuzumab) an 86% share, the lone biosimilar to Epogen (epoetin alfa) has just 37% market share seven years after its launch and the three biosimilars to Remicade (infliximab) have just a 49% share after nine years.

Steven Lucio, Pharm.D.

Market share and price differences don’t, however, necessarily align, according to figures in the Samsung Bioepis report. For example, the average sales price of the Remicade biosimilars is 79% lower than that of Remicade, whereas the average sale price of the Avastin biosimilars is 53% lower than that of their brand-name reference product, even though the Avastin biosimilars have a larger market share than the Remicade biosimilars.

The Samsung Bioepis report also has evidence of some large differences between wholesale acquisition cost (WAC) prices for biosimilars and their average sale prices, which are WAC prices after various discounts and rebates (but not 340B or Medicaid rebates) have been factored into the price. To take just one example, the difference between the WAC prices of the biosimilars to Avastin, Herceptin and Rituxan (rituximab) and those of their reference products is relatively modest, ranging from 10% to 25%. But the difference in the average sales prices between those biosimilars and their brand-name reference products ranges from 52% to 66%. The comparison between WAC and average sale prices is important because patient coinsurance and deductible are typically based on WAC prices, not the average sales prices, so in some cases, patients may not be benefiting fully from the discounting that occurs with biosimilars.

Newcomer says, though, patients are benefiting from the lower-priced biosimilars and that uneven and less-than-ideal development of the biosimilar market is a multifaceted problem. “I don’t think there’s just one lever that has held back biosimilars,” he says.

Biosimilars have a name recognition problem that may be a factor, in Newcomer’s opinion. “If I went and asked my mom and dad if they knew what a biosimilar was, there’s not a chance that they know what a biosimilar is,” he says. “If I asked them if they knew what a generic was, they would know the answer to that.”

Newcomer says a better job could be done with making employers and other payers more aware of the cost-saving benefits of biosimilars, perhaps through benefits consultants. “There are discussions that need to start happening in that sector that will bring better awareness to all of this,” Newcomer says.

The obstacles to adoption and market share have shifted, Burton says. In the late 2010s, after the approval of Zarxio and its launch several months later in September 2015, the challenge was convincing providers that biosimilars were just as safe and effective as the brand-name products. “The issues you saw early in the days of biosimilar adoption on the provider side are largely settled now,” says Burton. “The reasons for that are that we’ve seen that as a molecule has been on the market and providers have experience with it, they get much more comfortable with it, which makes sense.”

Stalking horse

That early-days generation of biosimilars was paid on the medical side of the health benefit and in Medicare Part B, which covers physician services and therefore infused drugs. “For the medical products, increasingly we see an acceptance and comfort and support on the part of providers, and it typically comes down to which products are most financially advantageous to the provider in a buy-and-bill setting,” says Burton, referring to the payment arrangement whereby reimbursement to providers for drugs is based on how much the providers paid for the drug plus a markup. Lucio says there has been a “little higher uptake” of biosimilars in provider settings because of the infrastructure for drugs — in-house pharmacists, formularies — in health systems: “Management has been a little more able to advance and make those decisions [in favor of biosimilars] where pharmacists work with doctors,” says Lucio.

It is a very different story for the biologics bought, sold and managed through pharmacy benefits and Medicare Part D, in Burton’s view. The pharmacy benefit biosimilars are biologics that can be self-administered, such as Humira, which is sold in prefilled syringes that patients use on their own. “For the pharmacy benefit products, it is all about the PBM,”
says Burton.

In Burton’s telling, for example, PBMs have rejected claims for the biosimilar insulin products. That didn’t necessarily translate into higher costs for the patients, he acknowledges. But in the long run, that’s shortsighted,he adds: “Biosimilars have to be more than just a stalking horse that allows you to get a bigger rebate from the reference product.”

When nine Humira biosimilars hit the market in 2023 after years of anticipation about brand-name Humira finally experiencing some competition, they had few takers and what was supposed to be a bang began as a whimper. The big three PBMs weren’t touching them, Burton notes. Then in early 2024, CVS Caremark announced that it was taking brand-name Humira off its main formularies starting in April 2024 and also entering into an agreement with AbbVie, Humira’s maker, to have a cobranded version of Humira available through its subsidiary, Cordavis. Burton says CVS Caremark switched 80% of its members treated with Humira to a biosimilar overnight. “It shows the power of the PBM once it decides that it’s in their interest to convert patients [to biosimilars],” notes Burton. “Whether it’s manifested in rebate deals, in fees, in private labels, that power — the unchecked power — of the PBMs is absolutely concerning,” he says

And that PBM power isn’t necessarily wielded on behalf of biosimilars, Burton says. “I would point out that more Humira patients have been moved to the next-generation brand products, Skyrizi [risankizumab] and Rinvoq [upadacitinib], in the time that the Humira biosimilars have been on the market than have been converted to the biosimilars.”

The year ahead

All eyes of the people who work in or observe the biosimilar industry are on the seven FDA-approved Stelara biosimilars, with two others under FDA review and a third in late-phase clinical development.

Jeff Casberg, M.S., vice president of clinical pharmacy at IPD Analytics LLC and a member of the Managed Healthcare Executive editorial advisory board, says the experience that payers have had with Humira biosimilars may make for earlier and broader coverage of the Stelara biosimilars. The catch: No payer has announced plans to remove brand-name Stelara from 2025 formularies. “The uptake of Stelara biosimilars will largely depend on how quickly brand-name Stelara is removed from formularies — not when biosimilars are added — and that may not happen until 2026,”
Casberg says.

Burton says the IRA may have the unintended consequence of delaying the Stelara biosimilar launches. Because Stelara was one of the first 10 drugs subject to CMS price negotiation under the IRA, it is guaranteed a spot on Part D formularies and Stelara biosimilars will be pitted against it. But if the biosimilar maker were to delay its Stelara biosimilar launch to the later part of the year, its product might be put on a formulary instead of Stelara, not alongside it. “You’re actually creating this nonsensical system where you, as a biosimilar maker, might be better off delaying your launch, depending on your coverage strategy,” Burton says.

Biosimilar makers are also hoping for some legislative action this year, The FDA has already issued guidance that begins to erase the interchangeability status. A bill has been introduced that would codify the end of a separate interchangeability designation. “There’s a lot that FDA can do, but at the end of the day, it would be cleanest for everyone if Congress were to pass legislation,” says Burton.