As employers and plan sponsors seek ways to provide comprehensive and affordable pharmacy benefits, it is helpful to understand how leveraging biosimilar medications can be key to managing specialty medication costs. These advanced therapies offer similar clinical efficacy and safety to their biologic counterparts while potentially reducing overall expenses.
What are biosimilars?
Produced to treat conditions such as cancer, Crohn's disease, and multiple sclerosis, biosimilar products are similar to the original biologic, or “reference,” drug, but they are not identical. They work much like generic drugs by introducing competition that may lead to significant specialty pharmacy savings, offering more treatment options without compromising effectiveness.
The Food and Drug Administration (FDA) requires all biologic products, including reference, biosimilar, and interchangeable products, to undergo strict evaluation for safety and efficacy. Biosimilars have no clinically meaningful differences in safety and effectiveness and must establish biosimilarity through clinical trial data.1
FDA approval and safety assurance for biosimilars
Like their reference products, biosimilars:
- Meet the FDA’s rigorous standards for approval
- Are manufactured in FDA-licensed facilities
- Are tracked as part of post-market surveillance to ensure continued safety2
Prescriptions for biosimilar products need to be written for the biosimilar by name. Biosimilar products that are granted interchangeability are allowed to be substituted for their reference biologic without the intervention of the prescriber. This is similar to how generic drugs may be substituted for brand name drugs.3
Specialty medication costs and the role of biosimilars
What role, then, should biosimilars play in your prescription benefit offering? Currently, 70+ biosimilar products are FDA-approved in the United States, presenting ample opportunities for employers to enhance the affordability of their pharmacy benefits while maintaining high standards of care.
However, we know the lowest overall cost strategy does not always mean the lowest cost drug based on market price. At CarelonRx, we will continue to position the best possible drugs that deliver the best health outcomes, measured by lower hospitalizations, lower emergency visits, fewer inpatient/outpatient admissions, fewer side effects, reduced adverse events, etc.
CarelonRx's approach to evaluating biosimilars
We approach biosimilars with the same rigor as the rest of our pharmaceutical approaches — ensuring our strategic direction aligns with external factors and drives the best outcomes, always focusing on clinical efficacy first and balancing with cost-effectiveness.
In evaluating available biosimilars, we balance several considerations, including federal and state regulations on interchangeability, specific biosimilar drug attributes, pricing, manufacturer rebates, and the ability for the biosimilar manufacturers to supply the marketplace. In this way, biosimilar utilization fits perfectly into our approach of managing and improving total member health.
CarelonRx maintains a firm commitment to providing optimal clinical and cost options for plan members, while supporting the fiscal responsibilities of the plan sponsors who provide them with their pharmacy benefit.
1. FDA: Review and Approval (accessed March 2025): fda.gov
2. FDA: Postmarketing Requirements and Commitments: Reports: (accessed March 2025): fda.gov
3. CarelonRx: Drug and Biologic Pipeline Update Q1 2025: carelonrx.com
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