Navigating Biosimilars and 505(b)(2) Drugs in Oncology: Operational, Clinical, and Policy Strategies for Pharmacists

At the 2025 Advanced Topics for Oncology Pharmacy Professionals Summit in Salt Lake City, Utah, biosimilars and 505(b)(2) drugs were a key focus in discussions on value-based cancer care. Though often less expensive than originator biologics or brand-name drugs, these therapies present operational, clinical, and regulatory challenges that pharmacists must navigate to optimize patient care. In an interview with Pharmacy Times®, Laura R. Bobolts, PharmD, BCOP, senior vice president of clinical strategy and growth at OncoHealth, offered insight into how pharmacists can lead the integration of these products into oncology practices. Drawing from her experience collaborating with payers and providers, Bobolts highlighted practical strategies to support formulary alignment, minimize workflow disruptions, and improve patient access to cost-effective oncology therapies.

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Up-Front Substitution

Biosimilar substitution, Bobolts explained, is most effective when implemented at the start of a new treatment regimen. This approach reduces the administrative burden and potential confusion associated with switching therapies midtreatment. “More commonly, preferred biosimilars are requested to be substituted up front when starting a new treatment,” Bobolts said. “This helps minimize disruption to workflows.”

Medicare regulations currently restrict step therapy involving biosimilars to new starts. In contrast, commercial payers have more flexibility to encourage substitutions midtreatment, particularly when the biosimilar’s safety and efficacy are well established. Bobolts pointed to a survey by the Alliance for Safe Biologic Medicines, the findings of which showed that nearly 80% of physicians reported feeling at least somewhat comfortable switching stable patients from a reference biologic to a biosimilar.

Payer Collaboration

Bobolts emphasized the importance of payer-provider collaboration in achieving successful biosimilar or 505(b)(2) product implementation. For payers, she advised selecting multiple preferred biosimilars or 505(b)(2) drugs to increase alignment with provider formularies.

“It’s also helpful for a payer to evaluate the prescribing patterns of their providers in advance,” Bobolts said. “This ensures that preferred products already match the market’s utilization and are as least disruptive as possible.”

Providers, in turn, should become familiar with the most common formularies and payer preferences in their patient populations. This helps ensure the provider selects the appropriate drug from the beginning, reducing any delays in care, coverage, or reimbursement, Bobolts explained. When a nonpreferred product is clinically necessary, she recommends that clinicians include clear documentation supporting the rationale for that choice to help expedite prior authorization.

Evaluating Success: Key Performance Indicators Beyond Utilization Rates

Beyond tracking utilization rates for preferred products, Bobolts highlighted several payer-side metrics that offer insight into the success of biosimilar and 505(b)(2) adoption. These include the rate of up-front changes to preferred products, the frequency of denials related to nonpreferred usage, and practice-level responsiveness to formulary education efforts.

“Some providers are highly responsive and align quickly, while others may require additional education,” she said. “Understanding these trends can help target interventions and streamline transitions more effectively.”

505(b)(2) Products: Not Generics, Not Biosimilars

Unlike traditional generics, 505(b)(2) drugs are new drug applications that rely partly on existing clinical data. Although often marketed as lower-cost alternatives to originator products, they are not therapeutically equivalent and cannot be automatically substituted. “Each 505(b)(2) product is treated as a unique entity, often with its own billing code, prior authorization requirements, and reimbursement pathway,” Bobolts said.

This creates operational complexities, particularly when multiple 505(b)(2) products are used to manage supply constraints or cost considerations. Furthermore, naming conventions for these products can contribute to confusion: Some have proprietary names, whereas others are referred to by their manufacturer, complicating prescribing and coverage decisions.

Medically Integrated Dispensing

Medically integrated dispensing (MID), where pharmacy services are embedded within oncology clinics, has emerged as a best practice for managing biosimilars and 505(b)(2) therapies. According to Bobolts, MID enables pharmacists to align drug dispensing with evidence-based institutional pathways and payer preferences in real time.

“Pharmacists in MID settings can help build EHR [electronic health record] treatment order sets using preferred drugs, educate providers and patients, and manage inventory proactively to prevent supply-related variation,” Bobolts said. This hands-on model promotes consistency in treatment and can reduce delays associated with prior authorization or reimbursement issues.

Cross-Team Coordination: The Pharmacist’s Role in Streamlining Access

Pharmacists are uniquely positioned to bridge clinical and administrative teams, ensuring that generic, biosimilar, and 505(b)(2) therapies are implemented efficiently. Bobolts emphasized proactive collaboration with revenue cycle and prior authorization teams to ensure alignment with payer formularies.

“By learning the preferred drugs for each payer, pharmacists can help ensure the right product is selected up front, avoiding unnecessary denials or delays due to mismatched coverage,” Bobolts said. This collaboration can significantly improve treatment timelines and patient satisfaction.

Financial Navigation

The availability of patient assistance programs (PAPs) and manufacturer co-pay support varies widely between originator biologics, biosimilars, and 505(b)(2) products. Originators typically offer the most robust support, whereas biosimilars may provide more limited assistance. Support for 505(b)(2) drugs is often minimal, Bobolts noted, as they are already marketed as cost-saving alternatives.

She warned that navigating these differences is crucial for financial navigation teams. “If a patient qualifies for a PAP for one product but the provider prefers another, the patient may need to be reenrolled in a new program, if one is even available,” she explained.

Looking Ahead

Asked what regulatory changes could streamline biosimilar and 505(b)(2) adoption, Bobolts pointed to therapeutic interchangeability as the ideal solution. “In my dream world, all biosimilars and 505(b)(2) drugs would be therapeutically interchangeable with the reference product,” she explained.

Such policy shifts could enable automatic substitution, reduce administrative burden, increase competition, and ultimately lower costs, mirroring the efficiencies seen with traditional generics. Although current regulatory frameworks do not permit this level of interchangeability, Bobolts remains optimistic about future progress: “A girl can dream, can’t she?”

Conclusion

As biosimilars and 505(b)(2) drugs continue to expand within the oncology treatment landscape, oncology pharmacists are essential to their successful implementation. Through strategic collaboration with payers, providers, and revenue cycle teams, pharmacists can lead efforts to align formularies, streamline authorizations, and maintain clinician and patient confidence in emerging therapies. With careful operational planning, medically integrated dispensing, and ongoing education, the oncology pharmacy community is well positioned to help maximize cost efficiency and quality in cancer care.