Why Operational Readiness Is The Missing Piece In Biosimilar Adoption

By Erica Blanchard, VP, pharmacy operations, and Angela Jeong, VP, clinical strategy, California Specialty Pharmacy

For more than a decade, healthcare leaders have debated the role of biosimilars in controlling specialty drug costs and expanding patient access to life-changing therapies. Today, many of those debates have largely been settled. In fact, a report from the Association for Accessible Medicines found that biosimilars generated $12.4 billion in savings for the U.S. healthcare system in 2023 alone, with $36 billion in cumulative savings since their introduction in 2015.¹

What Biosimilar Adoption Means From A Patient Perspective

For patients, the promise of biosimilars is not abstract. Many are living with chronic, complex conditions that require ongoing biologic therapy, and broader biosimilar adoption has the potential to support continued access to effective treatment while helping reduce pressure on overall healthcare costs. But those benefits are only realized when the transition from a reference biologic to a biosimilar is managed in a way patients can understand and trust. If a patient is told they will receive a medication with a different name than expected, or if the switch creates delays in authorization, scheduling, or delivery, what began as a cost-containment strategy can quickly become a patient experience challenge.

Biosimilars have demonstrated their clinical value, payors have increasingly incorporated them into formulary strategies, and adoption continues to grow across multiple therapeutic areas. The challenge now is how best to incorporate them into treatment plans from an operational perspective.

Biosimilars Are Not Generic Drugs

One reason operational readiness matters so much is that biosimilars and their relationship to biologics are fundamentally different from how generics compare to brand-name pharmaceuticals. While a generic pharmaceutical product is generally an exact chemical copy of the name-brand drug, this is not the case for biosimilars. While there are no clinically meaningful differences in safety, purity, and potency between biosimilars and the originator drugs, biosimilars are not exact copies.

As a result, generics can often be automatically substituted for brand-name pharmaceuticals at the pharmacy level, as allowed per state regulations, while biosimilars typically require additional coordination among prescribers, payors, and pharmacy teams.

What appears on paper to be a straightforward transition often involves multiple stakeholders and numerous operational steps before treatment can proceed with a biosimilar: coverage requirements must be verified, new prior authorizations may be necessary, and providers may need to approve a switch. Pharmacy inventory must align with payor preferences, and clinical teams must understand the specific product being administered.

That complexity is often overlooked by healthcare leaders when biosimilars are discussed primarily as a cost containment strategy.

For organizations responsible for administering infusion therapies, however, those operational realities are impossible to ignore. Every delay, missing authorization, formulary mismatch, or communication breakdown has the potential to impact patient care.

The Challenge Is No Longer Adoption, It's Execution

The more pressing question is no longer whether biosimilars work; it is whether healthcare organizations are prepared to implement them effectively.

Much of the industry's attention remains focused on policy decisions, contracting strategies, and projected savings. Yet the success (or failure) of biosimilars is ultimately determined somewhere far less visible: in the often-overlooked operational processes that occur between a formulary decision and a patient's infusion appointment.

The reality is that a successful biosimilar transition requires far more than selecting a preferred product. It requires coordination among payors, providers, pharmacists, nurses, reimbursement specialists, and patients themselves. The organizations that execute biosimilar transitions effectively understand that clinical equivalence is only the starting point. Operational readiness is what ultimately determines whether the promised benefits of biosimilars become reality.

From the patient’s perspective, this transition should not fundamentally change the care experience. The infusion appointment itself may look very similar, but the work required on the back end to support that appointment can change significantly. Teams may need to confirm the appropriate product, align coverage and authorization requirements, ensure inventory is available, educate clinical staff, and answer patient questions about why a medication name has changed. In some cases, biosimilars may also support lower healthcare costs or reduce patient affordability barriers, but patient-level cost exposure depends on benefit design, coverage requirements, and available assistance programs.

The Best Biosimilar Transition Is The One Patients Never Notice

One of the clearest lessons from infusion providers is that successful biosimilar adoption should be largely invisible to patients.

By the time a patient arrives for treatment, the complex work behind the scenes should already be complete. Coverage has been verified. Prior authorizations have been secured. Inventory has been aligned with formulary requirements. Clinical teams understand the therapy being administered. Patients have received appropriate education and know what to expect.

When these pieces are in place, the infusion experience itself changes very little. When they are not, administrative complexity quickly becomes a patient care issue. Delayed authorizations, coverage disputes, provider callbacks, inventory challenges and patient confusion can all create friction that undermines the goals biosimilars were intended to achieve.

In many ways, the success of a biosimilar strategy can be measured by how effectively organizations prevent operational challenges from ever reaching the infusion chair.

Patient Experience Is A Critical Part Of Adoption

Many patients receiving infused biologics have spent years finding a treatment regimen that works for them. Even when a biosimilar is clinically equivalent, a change in therapy can understandably generate questions:

• Will this treatment be as effective as the brand name?
• Will there be different side effects?
• Why am I receiving a medication that sounds different from the one my physician prescribed?

These concerns should not be viewed simply as barriers to biosimilar adoption. They are opportunities for education, trust-building, and more effective care coordination.

Specialty pharmacy infusion providers are uniquely positioned to address these questions because they often maintain frequent, ongoing contact with patients throughout treatment. Nurses, pharmacists, and care coordinators see patients repeatedly, answer questions in real time, and help navigate concerns as they arise. This ongoing relationship creates opportunities to build trust and reinforce confidence in biosimilar therapies.

Patient education is not simply a communications exercise, it is an operational requirement for successful biosimilar adoption. Organizations that fail to invest in educating and engaging patients risk creating unnecessary confusion, anxiety, and treatment disruptions that can ultimately undermine adherence, patient experience, and the broader goals biosimilars are intended to achieve

Where Policy Meets Reality

Payors have become increasingly sophisticated in their efforts to encourage biosimilar utilization. Preferred formularies, reimbursement policies, and utilization management strategies are helping drive adoption across the healthcare system.

But implementation does not occur at the policy level. It occurs when a provider writes an order, a pharmacist processes a prescription, a reimbursement specialist secures approval, and a nurse administers the therapy to a patient.

This is where specialty infusion providers can serve as a critical bridge between policy and patient care. Because they operate at the intersection of clinical care, reimbursement, and patient support, specialty infusion providers have visibility into challenges that may not be apparent to payors or health systems evaluating biosimilar strategies from a distance. They understand which products are preferred by specific health plans, how authorization requirements vary across payors, and where workflow bottlenecks are most likely to occur. They also understand how those administrative decisions ultimately affect patients.

In some cases, payor policies can create unintended operational challenges. Quantity limitations, for example, may not always align neatly with weight-based dosing requirements for infused therapies. A policy that appears straightforward on paper can become considerably more complicated when a patient is sitting in an infusion chair waiting for treatment.

The organizations that successfully scale biosimilar adoption are often those that anticipate these challenges before they occur.

Measuring Success Beyond Savings

Cost reduction remains one of the most compelling benefits of biosimilars. But healthcare leaders should resist the temptation to evaluate biosimilar initiatives solely by financial metrics. A truly successful biosimilar strategy should also improve operational performance and patient experience.

Healthcare organizations should evaluate biosimilar use by asking:

• Did patients experience delays in therapy initiation?
• Were transitions completed without disrupting continuity of care?
• Did patients remain adherent to treatment?
• Were providers comfortable with the transition process?
• Did patients understand and accept the change?
• Were clinical outcomes maintained?

Savings matter, but so do access, adherence, efficiency, and patient confidence. The most successful biosimilar programs achieve all these goals simultaneously.

Looking Ahead

The biosimilar landscape is poised for continued growth. More than 80 biosimilars have now received FDA approval, and new therapies, as well new indications for existing biosimilar products, continue to enter the market.² Policymakers are also exploring ways to reduce administrative barriers that slow adoption. For example, greater flexibility around interchangeability could further streamline implementation and reduce unnecessary operational burdens.

As adoption accelerates, the industry has an opportunity to move beyond viewing biosimilars solely as a pricing strategy. The next phase of biosimilar adoption will be defined by execution.

References

1. Association for Accessible Medicines. 2024 U.S. Generic & Biosimilar Medicines Savings Report. Association for Accessible Medicines, 2024, https://accessiblemeds.org/resources/reports/2024-savings-report/
2. “Biosimilar Product Information.” U.S. Food and Drug Administration, U.S. Department of Health and Human Services, https://www.fda.gov/drugs/biosimilars/biosimilar-product-information. Accessed 2 June 2026.

Legal Disclaimer:

The content provided in this blog post is based on industry experience and is for informational purposes only. It is not intended to serve as legal, regulatory, reimbursement, or medical advice. While we make every effort to provide accurate and up-to-date information, the details shared here should not be considered a substitute for professional consultation or advice.

By accessing this content, you agree to hold harmless the author, publisher, and any associated parties from any claims, liabilities, or damages arising from the use or interpretation of this content.

©2026 Acelpa Health, LLC. All rights reserved.

About The Authors

Erica Blanchard, PharmD, MBA, is an operations executive with extensive experience across specialty pharmacy, home infusion, ambulatory infusion, clinical trials, patient safety, and retail and inpatient pharmacy operations. She has led strategic and operational initiatives focused on process optimization, patient access, site-of-care solutions, and scalable growth within complex healthcare organizations. As vice president of pharmacy operations for CSP/HSP, Blanchard oversees pharmacy, nursing, and operational functions across California and Hawaii, with a focus on enhancing patient experience, strengthening clinical operations, and driving sustainable growth and operational efficiency.

Angela Jeong, PharmD, FCSHP, IgCP, APh, is a clinical strategy executive with extensive experience across specialty pharmacy, managed care, ambulatory care, and value-based healthcare. As Vice President of Clinical Strategy for CSP/HSP, Jeong leads clinical strategy initiatives that strengthen patient access, optimize specialty pharmacy programs, and advance innovative care models that improve quality, outcomes, and operational performance. She earned her Bachelor of Science degree in Psychobiology from the University of California, Los Angeles (UCLA) and her Doctor of Pharmacy degree from the University of Southern California School of Pharmacy. She completed an Ambulatory Care Residency at the USC LAC+USC Medical Center and is an Advanced Practice Pharmacist (APh), Fellow of the California Society of Health-System Pharmacists (FCSHP), and Immunoglobulin Certified Pharmacist (IgCP).

Ryan Skrable, chief business development officer, Acelpa Health, also contributed to this article.