Biosimilars 101: Maximizing biosimilar support for urology practices

What are biosimilars?
Biosimilars are FDA-approved biologic agents that are highly similar to their reference biologic products in terms of safety, efficacy, and potency. They provide the same clinical benefits, are administered at the same strength and dosage, and are not expected to cause new or worsening side effects.  

Since the first U.S. biosimilar approval in March 2015, the market has grown rapidly, with 82 approvals and 64 launches to date – making biosimilars one of the fastest-expanding segments in healthcare.  

Although biosimilars are often compared to generics, the analogy only goes so far. Generics are chemically identical to their brand-name counterparts. Biologics and biosimilars, however, are made from living cells, so they cannot be exact copies. Instead, all biosimilars begin with the same primary amino acid sequence as their reference biologic. Differences may exist in inactive ingredients, but these do not affect clinical performance.  

Biosimilars are now widely used across several therapeutic areas, including oncology, immunology, ophthalmology, endocrinology (insulins), and bone health. Their expanding role across specialties underscores their growing importance in urology, particularly as new products enter the market. 

Why biosimilars matter
Biosimilars offer meaningful advantages for patients, providers, and the healthcare system:

• More choice in treatment options
• Lower costs compared to reference biologics
• Improved patient access
• Reduced likelihood of innovator price increases 

From 2015-2024, biosimilars generated $56.2 billion in savings. Their lower price point can improve adherence and reduce financial burden for patients – though payer benefit design ultimately determines out-of-pocket costs. 

Understanding biosimilar interchangeability
For practices dispensing at the pharmacy level, interchangeability is an important operational consideration. Interchangeability is a regulatory designation that allows a pharmacist to substitute a biosimilar for its reference product – like how generics are substituted for branded drugs at the pharmacy level. However, interchangeability laws vary by state. 

Not all biosimilars are interchangeable. Manufacturers must submit additional data to support an interchangeability determination, including studies that compare outcomes for patients who alternate between the reference product and the biosimilar versus those who remain on the reference product. These studies must demonstrate no decrease in effectiveness or increase in safety risk associated with switching. 

Key considerations for urology practices
Adopting biosimilars requires thoughtful planning across clinical, operational, and financial areas, including:

• Payer mandates – Payers heavily influence biosimilar utilization. Some maintain exclusivity with reference products, while others mandate biosimilar use. Coverage varies widely by state and by payer.
• Average sales price (ASP) erosion – While competition is healthy, rapid ASP erosion can impact reimbursement. Strategic contracting is essential to maintain financial stability.
• Brand recognition & patient comfort – Patients accustomed to a specific injector or syringe may hesitate to switch. Education and shared decision-making are essential.
• Shared decision-making & staff education – Patients need to understand why a switch is occurring – whether due to payer requirements, clinical preference, or cost considerations. Staff must be prepared to support these conversations.
• Contracting & pricing – Biosimilars are a numbers game. Strong GPO partnerships help secure competitive pricing while preserving ASP.
• Inflation Reduction Act incentives – Enhanced add-on payments for select biosimilars, creating potential ROI advantages for Medicare populations.
• Inventory management – Multiple biosimilars for the same reference product can complicate storage and tracking – especially in regions with payer-specific requirements.
• Patient access programs – Not all biosimilars launch with robust support programs, so practices must protect patients from financial toxicity.
• Interchangeability – For dispensing practices, interchangeability remains a key operational factor. 

Cencora’s cycle of support
Cencora supports all biosimilars launched in the U.S. Successful biosimilar integration requires alignment across the payer landscape, GPO contracts, provider education, revenue cycle workflows, and inventory systems. Provider buy-in is also essential, as clinicians ultimately make therapy decisions for their patients. Through influence and leadership, we help manufacturers and customers expand access and generate demand. From advocating for access with manufacturers, to educating customers on safety and helping them realize mutual value and savings, to offering patients affordable alternatives that can positively impact adherence, we work across the full biosimilar ecosystem to advance the role of these therapies in specialty care. 

Cencora’s comprehensive support helps practices navigate biosimilar adoption with confidence. Through our specialty GPO, Specialty Practice Network (SPN), practices can access to strategic account managers, tools and reports that guide utilization, single-dose economics modeling, and robust contracting and pricing support. This is complemented by GPOConnect, our proprietary data platform that streamlines interactions, improves data accuracy, enhances transparency, and provides visibility into rebates, OID opportunities, and quarterly performance. Beyond operational tools, Cencora brings deep market expertise and advocacy – supporting all biosimilars launched in the U.S. by advocating for access, aligning interests with manufacturers, educating customers on safety and utilization, sharing strategic insights, and redesigning contract frameworks to unlock mutual value. Together, these capabilities help ensure that lower-cost alternatives reach patients, improving adherence, reducing financial burden, and advancing the role of biosimilars in specialty care. 

Finally, we offer a quarterly reference guide, U.S. Biosimilar Landscape, that outlines the current product landscape and potential future of this emerging market. This report is free and publicly accessible. Sign up to receive the quarterly biosimilars pipeline report.