From Promise to Proof: The Shakeup in Today’s Biosimilar Market

For years, the biosimilar story centered on approvals, pipeline growth, and the potential for long-term savings. That framing made sense when the market was still proving it could take shape in the United States. However, the market has moved past that stage, and the more pressing challenge now is whether biosimilars are reaching formularies, being prescribed in meaningful numbers, and delivering measurable savings in practice.

Recent market progress is undeniable. By the end of 2025, the FDA had approved 90 biosimilars across 20 biologic molecules, and 63 had been launched commercially.¹ Biosimilars have generated more than $56 billion in savings since 2015,² with the potential to save up to $181 billion under the right market and policy conditions. Those figures point to a category with real potential and real momentum. However, they don’t guarantee adoption. A biosimilar can exist, launch, and still fail to deliver broad savings if it never gains meaningful traction at the formulary and prescribing levels.

The biosimilar market now calls for a more practical standard of success. Approval counts still matter, but they no longer tell the full story. Commercial launch matters, too, but launch volume alone isn’t proof that the market is working as intended. The stronger measure is whether lower-cost biosimilar options are actually reaching patients, earning formulary support, and being adopted in a way that produces sustained savings over time.

Why Availability Is Only the Starting Point

Biosimilars were once framed mostly as a future cost-saving opportunity. Even so, availability on its own doesn’t lower spending. Savings depend on what happens after approval and after launch, when payer decisions, formulary positioning, prescribing habits, and operational follow-through begin to shape real-world use.

The latest market data shows why that matters. IQVIA reports that 118 biologics are expected to lose patent protection over the next decade, yet only 12 currently have biosimilars in development.³ Industry experts have described this as a potential biosimilar void, a warning sign that the market can’t assume future competition will arrive at the pace many expect.⁴ Even in the current market, approval and launch figures show progress, but not universal reach. As of late 2025, a major share of approved biosimilars hadn’t yet launched commercially. Patent cliffs may create opportunities, but opportunities alone don’t generate savings.

The same logic applies once biosimilars are available. A lower-cost alternative can’t change the economics of treatment if it’s poorly positioned on formulary, overlooked during prescribing, or introduced into a process that makes switching unnecessarily difficult. Market growth depends on what happens between the product’s existence and the patient’s actual uptake.

Why Is the Next Barrier Operational, Not Scientific?

Early biosimilar adoption was shaped in part by uneven provider familiarity with regulatory guidance and interchangeability, a factor that still influences prescribing and dispensing.⁵ That debate hasn’t vanished, but the market is now confronting a more practical challenge. Even when a biosimilar is clinically appropriate and financially attractive, adoption can stall if the route to prescribing it is unclear or cumbersome.

For many physicians, the barrier is operational drag. A lower-cost option may be available but never meaningfully used because the prescriber doesn’t have clear visibility into formulary status at the right moment, the preferred product is difficult to identify during routine prescribing, or the switching process requires extra manual effort that competes with other clinical priorities. The result is a market where lower-cost competition exists on paper, but savings remain trapped by friction in practice.

This is leading to a shift in the biosimilar conversation, one away from milestones alone and toward real-world uptake. The Center for Biosimilars has already pointed to a market entering a new phase in which PBM models and formulary decisions matter more than simple approval counts.⁶ Progress will depend more on whether the market can support practical uptake after launch.

How Does Formulary Support Shape What Gets Used?

Formulary support has become one of the most important tests of whether biosimilar competition will translate into lower spending. In theory, a lower-cost product should have a clear path to adoption. In practice, formulary position often determines whether that path is visible or obstructed.

A biosimilar that sits in a weak formulary position, lacks practical support from benefit design, or enters a reimbursement environment that blunts its advantage may do little to alter utilization. A biosimilar with strong formulary support and a practical prescribing path is far more likely to influence behavior. That’s why the current market phase requires greater attention to product placement, not just product presence.

This is also where the biosimilar market intersects with a broader pharmacy affordability problem. Cost savings aren’t automatic simply because a lower-cost option exists. Savings show up only when the system makes that option visible, actionable, and easy enough to use that it becomes part of routine care rather than an exception.

Why Must Real-World Uptake Become the Benchmark?

Meaningful adoption is the point at which biosimilar competition starts to matter beyond trade headlines and financial projections. Uptake shows whether physicians are prescribing available alternatives, whether payers and formularies are supporting that behavior, and whether patients are actually receiving those products at lower cost. Without that final step, projected savings remain theoretical.

Operational follow-through matters just as much. When the pathway from formulary opportunity to prescribed product is weak, the market leaves savings on the table. When lower-cost options are clearly surfaced and consistently supported, the market has a better chance of translating biosimilar availability into durable results.

Why Does the Market Need Better Follow-Through?

The most useful biosimilar conversation for the second half of 2026 centers on whether the industry is creating the conditions for real uptake across formularies, prescribing workflows, and routine pharmacy decision-making. Measurable savings depend on those factors working together, because even a market with a growing number of products can fall short when lower-cost options don’t translate into everyday use.

The biosimilar market already has enough proof that the category can matter. The bigger test now is whether lower-cost competition is reaching patients, gaining traction with prescribers, and producing savings that hold up well beyond launch announcements. Real progress will be measured by sustained uptake, stronger formulary support, and a clearer path from availability to use. How the market performs on those fronts will determine whether the next phase of biosimilar competition produces lasting savings or leaves much of its promise unrealized.

References

1. Samsung Bioepis Co Ltd. Samsung Bioepis releases first quarter 2026 US biosimilar market report, providing updates to evolving drug pricing models. Business Wire. January 23, 2026. Accessed May 12, 2026. https://www.businesswire.com/news/home/20260123492404/en/Samsung-Bioepis-Releases-First-Quarter-2026-US-Biosimilar-Market-Report-Providing-Updates-to-Evolving-Drug-Pricing-Models
2. Association for Accessible Medicines. 2025 U.S. Generic & Biosimilar Medicines Savings Report. Published September 3, 2025. Accessed May 12, 2026. https://accessiblemeds.org/resources/reports/2025-savings-report/
3. IQVIA Institute. Assessing the Biosimilar Void in the U.S.: Achieving Sustainable Levels of Biosimilar Competition. Published February 3, 2025. Accessed May 12, 2026. https://www.iqvia.com/insights/the-iqvia-institute/reports-and-publications/reports/assessing-the-biosimilar-void-in-the-us
4. Becker Z. As biosim industry confronts looming “void,” 2026 marks a chance to take stock and embrace changing landscape. Fierce Pharma. Published January 8, 2026. Accessed May 12, 2026. https://www.fiercepharma.com/pharma/us-biosimilar-landscape-marked-too-many-question-marks-shifting-policy-complex-market
5. Ling YL, Gentile D, Kotomale A, et al. Real-world familiarity with US biosimilar regulatory guidelines and interchangeability state laws among pharmacists and physicians treating immunological disorders. J Manag Care Spec Pharm. 2025;31(6):552-564. doi:10.18553/jmcp.2025.31.6.552