Biosimilars policy is moving from launch friction to access strategy
The next phase of biosimilars is no longer just about whether a lower-cost copy can reach the market. It is about whether patients can actually get the medicine once it exists, whether pharmacies can dispense it without unnecessary delays, and whether payer policy supports use at scale rather than narrowing it through administrative friction.
That was the core premise behind STAT’s virtual event, The Next Era of Biosimilars: Rewriting the Playbook, held Oct. 19, 2026. The discussion centered on a practical problem that has dogged biosimilar uptake since the earliest launches: access has often lagged behind scientific approval. Coverage rules, pharmacy policies, and channel decisions have frequently made the path from prescription to dispensing more complicated than it should be.
Access barriers sit between approval and patient use
The event framed early biosimilar adoption as a systems problem, not a molecule problem. In practice, a biosimilar can be clinically sound, regulatorily approved, and still fail to deliver its intended savings if reimbursement rules, formulary design, or pharmacy substitution policies slow uptake. For patients, the consequence is immediate: delay, confusion, or out-of-pocket burden at the point of care.
This is where interchangeability and payer economics enter the picture. When policy supports substitution pathways and health plans are willing to structure coverage with less friction, biosimilars can move from being a theoretical value proposition to a workable one. The event was built around that logic, asking how policy shifts and smarter plan design might make biosimilars both more accessible and more affordable.
A lower-priced biologic does not save money if patients never clear the access hurdle.
Thomas Rainey and Roxanne Schwans brought market access into focus
The conversation featured Thomas Rainey, senior vice president of U.S. Biosimilars at Teva Pharmaceuticals, and Roxanne Schwans, founder and CEO of OmniHealthRx Advisors. Their combined experience reflected two sides of the same market-access equation. Rainey has worked across sales, marketing, and commercial operations in oncology, neuroscience, and immunology, while Schwans has spent more than 30 years across biopharma, PBMs, and pharmacy advising manufacturers, payers, and health systems.
That mix mattered because biosimilars rarely rise or fall on clinical evidence alone. Their uptake depends on how manufacturers position the product, how payers build coverage policies, and how pharmacy channel decisions affect real-world dispensing. In a market where originator biologics often retain entrenched contracting power, biosimilar competition has to overcome both inertia and operational complexity.
Interchangeability policy can remove unnecessary drag
The event description placed interchangeability near the center of the discussion, and for good reason. In the biosimilar world, interchangeability is not an abstract regulatory label; it is a policy lever that can shape whether substitution happens seamlessly or stalls behind extra administrative layers. For clinicians and pharmacists, the label can influence confidence in switching. For payers, it affects formulary strategy. For patients, it can determine whether treatment begins on time.
The logic is straightforward. When policies recognize that a biosimilar can be substituted appropriately, the system needs fewer handoffs and fewer points of delay. That is especially important in chronic disease treatment, where patients may be receiving repeated biologic therapy and where every pause increases the chance of lost adherence or abandoned prescriptions.
Policy shifts alone will not fix biosimilar adoption, but they can clear the path enough for the economics to work as intended.
Supply predictability has become part of the clinical conversation
The event also emphasized supply predictability, a reminder that affordability means little if availability is unstable. Biologics are not simple small-molecule tablets; they sit inside a manufacturing and distribution chain that can create bottlenecks. If supply is unpredictable, pharmacy planning becomes harder and payer confidence weakens. If supply is steady, the case for broader adoption becomes easier to defend.
This has direct clinical implications. Patients do not experience a biosimilar as a policy category. They experience it as whether a prescription can be filled, whether the pharmacy has stock, and whether the therapy remains continuous over time. In that sense, supply predictability is part of treatment continuity, not just procurement.
Payer economics determine whether savings reach the bedside
The discussion also turned to smarter payer economics, a phrase that captures one of the biggest unresolved issues in biosimilars. Lower list pricing does not automatically translate into lower patient costs or broader access. The economics depend on formulary placement, rebate strategy, contracting behavior, and how much of the savings are actually passed through to patients and clinicians.
That is why the event positioned biosimilar adoption as a systems-level efficiency challenge. A drug may be less expensive in principle, but the final economics can be distorted by the way health plans and pharmacy benefit structures distribute incentives. If those incentives favor the incumbent product, biosimilar uptake can remain muted even when the clinical rationale is sound.
From a bedside perspective, the stakes are concrete. If a biosimilar reduces friction in coverage and pharmacy policy, more patients can start therapy earlier and stay on it longer. If the system adds complexity, access erodes before the first dose is ever administered.
The practical question now is execution
The event did not present a trial readout or a regulatory announcement. Its value lay elsewhere: it treated biosimilar adoption as an execution problem that spans policy, supply, and reimbursement. That framing is useful because it matches the reality of modern biologic care. The challenge is not simply proving that biosimilars exist or that they can work. The challenge is building a market structure that lets patients reach them without avoidable delays.
With Thomas Rainey representing a major biosimilar developer and Roxanne Schwans bringing payer and channel expertise, the discussion reflected how many moving parts still shape this class of medicines. The next phase of biosimilar use will depend less on whether the products are available and more on whether coverage rules, substitution pathways, and supply systems are aligned enough to let them function as intended. For now, the most important unanswered operational issue is not scientific validity but whether the surrounding system can finally stop getting in the way.