Apr 15
Published on Pharma Focus America
Introduction
The Execution Gap
The biosimilar market in 2026 represents one of the most significant commercial opportunities in the pharmaceutical industry's history. The U.S. Food and Drug Administration (FDA) approved a record 18 biosimilars in 2025, spanning oncology, immunology, ophthalmology, and metabolic disease, including insulin biosimilars. Since their introduction in 2015, biosimilars have generated over USD 56.2 billion in U.S. healthcare savings. In the fastest-growing therapeutic categories, including oncology, ophthalmology, and pegfilgrastim, biosimilars have captured 81 per cent market share within five years of launch.
The science is working. The regulatory pathway is maturing
Yet a persistent, systematic gap exists between the commercial potential of biosimilar programmes and the revenue they actually generate. This execution gap is most acute at growth-stage and mid-sized biosimilar companies launching their first or second product, without the institutional payer infrastructure of a large pharmaceutical biosimilar division. Scientifically sophisticated companies are consistently underperforming against their launch models. Not because their products are clinically inferior. Rather, market access strategies have been built too late, designed too narrowly, and executed without sufficient understanding of how the payer landscape has fundamentally shifted over the past 24 months.
This is the biosimilar execution gap. It is costing companies hundreds of millions in unrealised revenue. And it is almost entirely preventable.
Three Structural Shifts
Three structural forces have converged to reshape the biosimilar commercial landscape simultaneously.
Pharmacy Benefit Manager Consolidation
The three largest pharmacy benefit managers (PBMs), namely CVS Caremark, Express Scripts (Cigna), and OptumRx (UnitedHealth Group), now control formulary access for the majority of commercially insured lives in the United States. Their market power has grown to a point where formulary exclusions are no longer the exception. They have become standard practice. Express Scripts added 129 new formulary exclusions in 2026 alone, reflecting a systematic approach to formulary management that prioritises economic relationships over clinical equivalence.
More significantly, PBMs are no longer purely intermediaries in the biosimilar market. CVS Caremark's Cordavis subsidiary, most prominently in the adalimumab category but with stated intentions to expand across therapeutic areas has emerged as a direct commercial participant. It launches private-label biosimilar versions of high-volume reference biologics and places them preferentially on Caremark formularies. This creates a competitive dynamic that was absent when most biosimilar companies constructed their commercial models. The gatekeeper and the competitor have become the same entity.
Legislative Reform
The Consolidated Appropriations Act of 2026, signed in February 2026, prohibits PBMs from earning compensation tied to drug prices, rebates, or volume-based incentives in Medicare Part D. It also requires enhanced transparency reporting on formulary placement rationale. The reforms are scheduled to take effect between 2028 and 2029. Whilst PBM industry groups have signalled potential legal and regulatory challenges, and implementation details remain subject to rulemaking, the directional signal from Congress is clear. Rebate-linked compensation in Medicare Part D is being structurally constrained. Building market access strategies that are resilient to this transition is prudent regardless of the precise implementation timeline.
Average Sales Price Compression
For biosimilars reimbursed under Medicare Part B, Average Sales Price (ASP) dynamics have proven more volatile than launch-year forecasting typically anticipated. In the most competitive biosimilar categories, the U.S. Department of Health and Human Services Assistant Secretary for Planning and Evaluation (HHS ASPE) confirmed that biosimilar competition reduced Medicare Part B spending by 62 per cent in 2023. This figure illustrates the magnitude of ASP compression that companies in multi-entrant biosimilar markets must model explicitly. The 2026 Medicare Physician Fee Schedule further introduced significant new ASP reporting methodology changes effective from 1 January 2026, adding further complexity to the reimbursement-modelling environment.
Companies that constructed five-year commercial models on static ASP assumptions are now operating with a materially incorrect financial picture.
Four Failure Points
Against this backdrop, four specific execution failures account for the majority of biosimilar commercial underperformance.
Failure Point 1. Market Access Treated as a Launch Activity
The most common and most expensive mistake in biosimilar commercialisation is treating payer strategy as a task to be addressed in the twelve months before launch. By the time a Biologics Licence Application (BLA) is filed, the market access architecture should already be operational. Payer relationships take years to develop. Formulary positioning requires evidence packages that demand significant time to build and validate. The companies capturing the strongest formulary positions in 2026 began their payer engagement programmes in 2022 and 2023.
When market access teams are being hired as the Prescription Drug User Fee Act (PDUFA) date approaches, the company is already behind. No degree of execution excellence in the launch year will fully compensate for the relationships and evidence that were not built during development.
Failure Point 2. The PBM Affiliate Dynamic Underestimated
Most biosimilar commercial teams understand PBM formulary dynamics in theory. Fewer have constructed their commercial strategies around the specific economics of PBM affiliate relationships at the contract level.
The emergence of PBM-affiliated private-label biosimilars has created a new competitive threat that demands a fundamentally different response to traditional PBM contracting. Understanding which formularies are most exposed to private-label preference, which therapeutic categories carry the greatest risk, and what evidence package is required to compete effectively against an affiliated product requires analysis that extends well beyond standard payer landscaping. Companies that have not specifically modelled the PBM affiliate scenario in their commercial planning are operating without visibility into one of the most material risks in their launch model.
Failure Point 3. Evidence Package Built Too Late
In 2026, payers are requesting real-world evidence, comparative effectiveness data, and pharmacovigilance records that demonstrate a biosimilar performs as expected in actual clinical settings, rather than solely in the controlled environment of registration trials. This evidence requires time to generate. It cannot be accelerated by committing additional resources in the year before launch.
The biosimilar companies holding the strongest formulary positions in 2026 began generating real-world evidence from compassionate use programmes, registry data, and post-marketing studies well in advance of commercial launch. Their evidence packages, when presented to payer medical directors, reflected years of data collection rather than months.
Evidence generation strategy must therefore function as a development-phase workstream, not a commercial-phase workstream. Medical affairs and market access functions need alignment on evidence requirements by the time a Phase 3 programme is underway.
Failure Point 4. Fragmented Commercial Planning
Reimbursement strategy for biosimilars is not a standalone workstream. It intersects with pricing strategy, patient services design, specialty pharmacy contracting, site-of-care strategy, and medical affairs. In companies where these functions operate as separate silos, each reporting to different leadership and operating on different timelines, the commercial plan that emerges is systematically weaker than the sum of its parts.
Formulary contracting teams negotiate prices that patient services teams cannot support through co-pay assistance models. Specialty pharmacy networks fall out of alignment with site-of-care strategies. Medical affairs evidence packages fail to address the specific objections that payer medical directors raise.
The structural remedy is straightforward but organisationally challenging. A single profit-and-loss (P&L) owner for market access, with direct authority over pricing, contracting, patient services, and specialty pharmacy, should report to the Chief Executive Officer rather than the Chief Commercial Officer. Market access functions positioned below the Chief Commercial Officer level consistently lose resource allocation decisions to sales and marketing priorities in the months preceding launch. These misalignments are predictable, preventable, and consistently underestimated in pre-launch planning.
What Effective Market Access Looks Like
Sidebar: Five Characteristics of Market Access Leaders
The biosimilar companies executing market access most effectively in 2026 share five distinguishing characteristics.
First, they appoint a single executive accountable for the full market access ecosystem, covering pricing, contracting, formulary management, reimbursement, patient services, and specialty pharmacy, from the earliest stages of commercial planning. This is a leadership role with cross-functional authority and direct board-level reporting.
Second, they begin payer engagement three or more years before launch. This engagement is relationship-based, educational, and evidence-led. The objective is to ensure that payer medical directors have reviewed the clinical data, understand the pharmacoeconomic case, and have an established relationship with the commercial team before formulary placement discussions begin.
Third, they construct scenario-based reimbursement models that explicitly stress-test ASP compression, PBM affiliate competition, and formulary exclusion scenarios, including scenarios in which their product is excluded from a major formulary in the first year post-launch. Companies that have modelled these scenarios respond to them decisively. Those that have not responded with reactive price concessions that further compress margins.
Fourth, they treat the Consolidated Appropriations Act of 2026 as a strategic opportunity rather than a compliance obligation. The reforms taking effect in 2028 to 2029 will structurally advantage biosimilars with strong clinical and economic evidence packages. Formulary placement decisions will increasingly require justification on clinical and economic grounds rather than rebate economics. Building that evidence base now creates a durable competitive advantage.
Fifth, they invest in interchangeability designation. As discussed in the following section, this commercial lever remains systematically underutilised.
The Interchangeability Opportunity
One dimension of biosimilar market access that remains systematically underinvested is the pursuit of interchangeability designation.
An interchangeable biosimilar may be substituted for the reference biologic at the pharmacy level without prescriber intervention, the same legal standard applied to small molecule generic substitution. As biosimilar substitution legislation continues to expand across U.S. states, currently enacted in the majority of states, the commercial value of the interchangeability designation is growing. Companies that have not pursued it are foreclosing a commercial option that is becoming increasingly material to launch outcomes.
The FDA's evolving interchangeability guidance has made the designation more accessible than it was five years ago. The clinical and regulatory investment required to achieve interchangeability is meaningful. The commercial return, reflected in formulary placement, pharmacy substitution rates, and payer preference, is equally so.
Companies that are not actively pursuing interchangeability designation for their lead biosimilar programmes in 2026 are leaving a significant commercial lever unused.
Key Takeaways
Box: Four Actions for Biosimilar Commercial Leaders
The following four actions represent the highest-leverage steps available to biosimilar commercial teams in 2026.
Begin payer engagement immediately, regardless of how distant the PDUFA date appears. The three-year minimum timeline for meaningful formulary relationships is not negotiable in the current market.
Conduct a PBM affiliate audit. Map which formularies carry meaningful Cordavis or equivalent private-label exposure in the target therapeutic category and build a differentiated contracting and evidence strategy for each.
Align medical affairs and market access on a shared evidence generation roadmap with milestones tied to development-phase decisions, not commercial-phase milestones.
Appoint a single market access P&L owner with cross-functional authority and CEO-level reporting before the commercial organisation is fully built.
Conclusion
The biosimilar market opportunity in 2026 is real, large, and growing. The Consolidated Appropriations Act reforms, the continued expansion of the biosimilar pipeline, and the maturation of payer understanding of biosimilar clinical equivalence represent meaningful structural tailwinds.
The window for capturing that opportunity, however, is not indefinitely open. PBM affiliate programmes are expanding. Private-label biosimilar portfolios are growing. Companies that are building payer relationships, generating real-world evidence, and developing integrated market access strategies today will be significantly better positioned than those that delay.
The gap between winning and losing in biosimilars in 2026 is rarely a science gap. It is usually an execution gap. And execution gaps are invariably a leadership choice.
