Biologic Stewardship: The Next Frontier for Health System Pharmacists

Biologic therapies rank among the most costly, highest-risk, and rapidly expanding medications in health care systems; however, numerous institutions lack a formal infrastructure for biologic stewardship. Pharmacists are uniquely positioned to lead safe, cost-effective, and evidence-based management of biologics.

The Rapid Expansion of Biologic Therapies

The use of biologic therapies has expanded rapidly over the past decade, transforming the treatment landscape for autoimmune diseases, inflammatory disorders, oncology, and rare diseases. Since the 1970s, biologic therapies have transformed health care, significantly affecting immune-mediated conditions such as inflammatory bowel diseases and rheumatoid arthritis. Biologics constitute an increasing portion of the market, and the research and development of biologic agents are expected to grow as technologies advance.¹

Monoclonal antibodies, targeted immunomodulators, biosimilars, and gene-directed therapies are increasingly being used to improve disease control and outcomes in patients who previously had limited therapeutic options. As indications continue to broaden, biologics represent some of the most clinically impactful yet financially burdensome medications in health systems. This rapid growth has introduced new challenges related to medication access, safety monitoring, formulary management, and long-term treatment optimization.

Why Biologic Stewardship Is Needed

Biologic stewardship is increasingly needed as the use of high-cost, high-impact therapies expands, creating parallels to the earlier rise in antimicrobial utilization. Much like antimicrobial stewardship programs were developed to optimize antibiotic selection, duration, and resistance prevention, biologic stewardship focuses on ensuring appropriate patient selection, guideline-concordant initiation, and ongoing efficacy reassessment to prevent unnecessary or duplicative therapy.

A meta-analysis of 28 pharmacist-driven stewardship initiatives found a significant reduction in mortality (risk ratio [RR], 0.68; 95% CI, 0.59-0.79) and a marked decrease in inappropriate antimicrobial use (RR, 0.36; 95% CI, 0.32-0.39), highlighting the clinical and safety benefits of structured oversight.²

Moreover, biologics introduce additional complexity through payer-driven access barriers, prior authorization requirements, safety monitoring, or immunosuppression-related risks. Even when a biologic is considered the optimal choice by health care professionals, insurance may hinder or complicate access to prompt and affordable care. For patients to obtain appropriate treatment, they must understand how to navigate these obstacles.³

The Pharmacist’s Role

Health system pharmacists are central in advancing biologic stewardship through a combination of clinical oversight, operational expertise, and interdisciplinary collaboration. Pharmacists are fully equipped to optimize formulary management, streamline prior authorization processes to reduce delays, and develop biosimilar conversion programs that maintain clinical equivalence while improving cost efficiency. Pharmacists also play a key role in establishing and maintaining laboratory monitoring protocols and ongoing safety surveillance for immunosuppression-related risks. In addition, pharmacists support adverse effect management and adherence monitoring to optimize long-term therapeutic outcomes. Although integrated systems often rely on standardized formularies and coordinated care pathways, academic specialty pharmacy models may emphasize patient access services and longitudinal therapy support.

Biosimilars as a Stewardship Opportunity

Biosimilars represent one of the most immediate and scalable opportunities to advance biologic stewardship within health systems, particularly amid rising specialty drug expenditures and expanding biologic utilization. By offering clinically equivalent alternatives to originator biologics at reduced cost, biosimilars can meaningfully reduce financial burden on health systems and patients while expanding access to essential therapies. However, their adoption has been variably slowed by provider hesitancy, often driven by concerns regarding interchangeability, efficacy, and immunogenicity.^4-6

Pharmacists can address these challenges through evidence-based education, protocol development, and leadership of biosimilar conversions. In addition, pharmacist-led patient counseling is important for reinforcing confidence, addressing misconceptions, and supporting adherence when switching from reference products to biosimilars.

Coordination of Care

Transitions between inpatient and outpatient settings represent a clinical vulnerability point in biologic therapy management where gaps in communication, formulary alignment, and follow-up monitoring can lead to therapy disruption, duplication, or suboptimal outcomes. Patients initiated on biologics during hospitalization may encounter barriers upon discharge, including insurance reauthorization requirements, site-of-care restrictions, and changes in formulary-preferred agent—all of which can delay continuity of care.^4,7

Conversely, patients on stable outpatient biologic regimens may require careful reconciliation during inpatient admissions to avoid unintended interruptions and substitutions. Pharmacists play a pivotal role during these transitions by ensuring accurate medication reconciliation and coordination with specialty pharmacies and payers. In addition, proactive communication between inpatient teams, outpatient providers, and pharmacy services helps maintain therapeutic consistency, ultimately supporting safety and continuity in complex immunologic care.

The Future of Pharmacist-Led Biologic Stewardship

The future of pharmacist-led biologic stewardship will be shaped by increasing integration of specialty pharmacy services into health system care models, enabling more seamless coordination of access, monitoring, and longitudinal patient support. Collaborative practice agreements will further expand pharmacists’ authority to initiate, adjust, and monitor biologic therapies, particularly in chronic immune-mediated and rare disease states in which timely optimization is essential. Emerging technologies, including artificial intelligence–assisted monitoring tools, are expected to enhance real-time identification of safety signals, adherence concerns, and utilization patterns, allowing for more proactive and data-driven stewardship interventions.

Simultaneously, pharmacoeconomic stewardship will become increasingly important as health systems seek to balance clinical benefit with the rising costs of advanced therapeutics, such as gene and cell therapies that introduce new complexities in budgeting, durability assessment, and outcomes tracking. As these innovations converge, pharmacists will be uniquely positioned to lead the evolution of biologic stewardship frameworks. Health system pharmacists are positioned not only to manage biologics but also to define the stewardship framework governing their safe and sustainable use over the next decade.

REFERENCES

1. The rise of biologics: emerging trends and opportunities. CAS. 2023. Accessed May 15, 2026. https://web.cas.org/marketing/pdf/CASBIOENGWHP101215-CAS-IP-Biologics-Innovation-White-Paper.pdf

2. Mahmood RK, Gillani SW, Saeed MW, Vippadapu P, Abdulla Alzaabi MJM. Impact of pharmacist-led services on antimicrobial stewardship programs: a meta-analysis on clinical outcomes. J Pharm Health Serv Res. 2021;12(4):615-625. doi:10.1093/jphsr/rmab036

3. Navigating insurance barriers for biologic medication. Alliance for Patient Access. July 2025. Accessed May 15, 2026. allianceforpatientaccess.org/wp-content/uploads/2025/07/AfPA_Biologics-WG_Navigating-Insurance-Barriers_One-Pager_July2025.pdf

4. O’Reilly KB. Time to scrutinize PBMs’ outsized role in Rx decision-making. American Medical Association. June 10, 2019. Accessed May 15, 2026. https://www.ama-assn.org/house-delegates/annual-meeting/time-scrutinize-pbms-outsized-role-rx-decision-making

5. Caffrey M. The Trump sequel: what to expect on PBMs, 340B, drug pricing, and RFK Jr. AJMC. November 12, 2024. Accessed May 15, 2026. https://www.ajmc.com/view/the-trump-sequel-what-to-expect-on-pbms-340b-drug-pricing-and-rfk-jr

6. Schmalzing M, Askari A, Girolomoni G, Perez-Coleman JCV, Salvati C, Bachinskaya E. Clinical and real-world evidence on etanercept biosimilar switching: a narrative literature review of efficacy and safety. Adv Ther. 2026;43(1):49-75. doi:10.1007/s12325-025-03367-5

7. Jeremias S. Overcoming challenges to improve access and reduce costs. The Center for Biosimilars. November 12, 2024. Accessed May 15, 2026. https://www.centerforbiosimilars.com/view/overcoming-challenges-to-improve-access-and-reduce-costs