Biosimilars lower biologic costs and widen access.
Biosimilars have made treatment more affordable for diseases that previously had no options or were too expensive to treat. Patients diagnosed with colorectal cancer, certain autoimmune diseases such as rheumatoid arthritis, and even macular degeneration now have greater treatment alternatives to improve their quality of life.
A biosimilar is “a biologic agent with high similarity to a licensed reference product, which has expired patency and has no clinically meaningful differences regarding safety, efficacy, and quality.”1 Some patients may have concerns about biosimilars in much the same way as they do for generic equivalents of small-molecule drugs. Although biosimilars and their origin biologics are not identical, they “undergo a restricted regulatory standard pathway designed to ensure compliance with stringent standards of similarity to their reference biologics.”2
Despite lingering patient concerns, health care providers are increasingly accepting of biosimilar use across inpatient and outpatient settings. Understanding and explaining key terminology can help patients feel more comfortable with initiating a biosimilar treatment. These key terms include switching, interchangeability, substitution, and automatic substitution.2
Formulary decisions for biosimilars should carefully weigh clinical trial data, real-world evidence, and the needs of the intended patient population.1 One major benefit of biosimilars is their potential to reduce health care spending. Biologic therapies are often among the most expensive medications used in oncology, rheumatology, endocrinology, and other specialty areas. By offering lower-cost alternatives, biosimilars can improve patient affordability and expand access to essential treatments. Despite these advantages, barriers such as provider hesitation, patient misconceptions, and regulatory complexities have previously limited their widespread adoption.3
Pharmacists are uniquely positioned to address these challenges through evidence-based approaches. First, pharmacists serve as key educators for both patients and health care providers. They can discuss the rigorous FDA approval process for biosimilars, emphasizing that these agents undergo extensive comparative studies to ensure safety, efficacy, and clinical outcomes comparable to those of their reference biologics.4
Patient counseling is also essential, as individuals may feel uncertain or anxious about switching from a familiar biologic to a biosimilar. By providing clear information and reassurance, pharmacists can help build patients’ confidence and promote acceptance. Of course, counseling on the drug itself, including expectations for health outcomes, adverse effects, drug interactions, proper use and storage, and contraindications, remains paramount.
Additionally, pharmacists play a critical role in formulary decision-making and medication management within health care systems. They evaluate clinical evidence, cost-effectiveness, and interchangeability status to guide appropriate product selection. Pharmacists also assist in developing institutional policies that support safe substitution practices in states where substitution is permitted by law.4
Pharmacists can also contribute significantly to pharmacovigilance and ongoing monitoring. Because biosimilars are relatively new therapies, ongoing safety monitoring is crucial to ensure optimal patient outcomes. Pharmacists can support accurate documentation of product names and batch numbers, report adverse events, and monitor patient response during therapy transitions.3
Pharmacists also have an important leadership role in institutional formulary decisions regarding biosimilars. Developing a structured guide for evaluating biosimilars enables pharmacy teams to standardize criteria for product selection, taking into account efficacy, safety, cost-effectiveness, and the patient population served. By establishing clear institutional protocols, pharmacists can promote consistency in prescribing practices, reduce variability in patient care, and encourage confidence among providers when introducing biosimilars. Educating the health care team about clinical evidence, interchangeability, and regulatory requirements is a critical component of this leadership function.5,6
Shahin Teimourtash, MD; Beatriz Rubio, MSc; and Shelby Luna are PharmD candidates at the Touro University California College of Pharmacy.
Shane Desselle, RPh, PhD, is a professor of social and behavioral pharmacy at the Touro University California College of Pharmacy.
Safety considerations are another area where pharmacists provide oversight. Evidence from systematic reviews indicates that switching patients from reference biologics to their biosimilars is generally safe and does not increase the risk of adverse events or reduce therapeutic efficacy.6 Pharmacists can disseminate these findings to prescribers and patients, addressing hesitancy and misconceptions while supporting evidence-based decision-making.
Clinical pharmacists also facilitate uptake by guiding appropriate substitution practices and helping integrate biosimilars into outpatient and specialty pharmacy workflows.6 They monitor patient response, manage potential adverse events, and document product-specific information to ensure accurate pharmacovigilance, a key factor in long-term biosimilar adoption. Additionally, pharmacists can assist in cost-benefit analyses to demonstrate the economic impact of biosimilars within health care systems, further supporting leadership in formulary management.
Ultimately, the involvement of pharmacists extends beyond dispensing. By leading educational initiatives, guiding formulary decisions, monitoring safety, and promoting evidence-based use, pharmacists enhance patient access to biologic therapies while supporting sustainable health care practices. The pharmacists’ multifaceted role underscores the critical intersection of clinical expertise, leadership, and patient advocacy in the successful implementation of biosimilars across diverse health care settings.5,6
