ATOPP 2025: Navigating Biosimilar Adoption and Operational Strategies in Oncology

At the 2025 Advanced Topics for Oncology Pharmacy Professionals (ATOPP) Summit in Salt Lake City, Utah, experts discussed the complexity of biosimilars and 505(b)(2) drugs in cancer care. In an interview with Pharmacy Times®, Laura R. Bobolts, PharmD, BCOP, senior vice president of Clinical Strategy and Growth at OncoHealth, shared insights on optimizing biosimilar substitution, navigating payer mandates, and overcoming the unique clinical and reimbursement challenges posed by 505(b)(2) products.

Drawing from her experience working with both payers and providers, Bobolts outlines practical strategies for pharmacists to support formulary alignment, minimize workflow disruptions, and enhance patient access to cost-effective oncology therapies.

Pharmacy Times: How do you recommend operationalizing biosimilar substitution in a way that maintains clinician confidence and minimizes disruption to workflows?

Laura R. Bobolts, PharmD, BCOP, senior vice president of Clinical Strategy and Growth at OncoHealth in Miami, Florida.

Laura R. Bobolts, PharmD, BCOP: More commonly, preferred biosimilars are requested to be substituted upfront, when starting a new treatment. This helps minimizes disruption to workflows. For example, step therapy to support biosimilars for Medicare members is only allowed for patients starting a new course of therapy. In contrast to Medicare, commercial payers have more flexibility to encourage or require biosimilar substitution mid-treatment, especially in cases where the evidence for biosimilar efficacy and safety is well-established. A survey by the Alliance for Safe Biologic Medicines found 79.8% of physicians felt very or somewhat comfortable with switching a stable patient from an originator medicine to a biosimilar.

Pharmacy Times: What strategies have proven most effective for managing payer preferences and formulary mandates when introducing biosimilars or 505(b)(2) products?

Bobolts: My best advice is for a payer to select multiple biosimilars or 505(b)(2) products as preferred, so clinicians have options to choose from. This increases the likelihood the payer has selected a product that matches the practice’s formulary. It is also very helpful for a payer to evaluate the prescribing patterns of their providers in advance to ensure they are selecting preferred biosimilars or 505(b)(2) products that already match their market’s utilization. The goal is to be as least disruptive as possible, while still driving towards more cost-effective cancer care. In addition, one novel tool some payers leverage is to remove the prior authorization requirement from certain preferred biosimilars or 505(b)(2) products to promote utilization and reduce the administrative burden on the provider.

Alternatively, my best advice for providers is to learn the formulary options and preferred biosimilars and/or 505(b)(2) drugs for the most common payers that represent their patient mix. This helps ensure the provider selects the appropriate drug from the beginning, reducing any delays in care, coverage, or reimbursement. All patients are unique, and payers recognize that. If a non-preferred or non-formulary drug is best fit for that patient, the treating physician should consider providing the rationale for treatment selection upfront to help expedite the coverage determination.

Pharmacy Times: Can you discuss specific metrics or KPIs your team uses to evaluate the success of biosimilar or generic adoption across oncology service lines?

Bobolts: There are additional metrics of success from the payer perspective beyond the common percentage of preferred drug (ex: preferred biosimilar, generic drug, or 505(b)(2) drug) utilization. For example, payers may look at metrics such as the rate of upfront change to the appropriate preferred agent, the rate of denials for not changing to the preferred product, and what providers and practices are most receptive to the preferred drug strategy versus those commonly unresponsive, requiring additional education.

Pharmacy Times: What unique challenges do 505(b)(2) drugs pose from an operational or clinical standpoint, and how should pharmacists prepare for them?

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Bobolts: 505(b)(2) drugs present a distinct set of operational challenges, even some that were not anticipated. A key issue is that, although these drugs may share the same active ingredient or even resemble the reference drug in name, they are not generics and are not considered therapeutically equivalent. As a result, they cannot be automatically substituted. Each 505(b)(2) product is treated as a unique entity, often with its own billing code and reimbursement pathway. If prior authorization is required, it may need to be obtained separately for each individual 505(b)(2) product, especially if multiple products are used due to supply constraints, resulting in added administrative burden for both payers and providers. Also, the nomenclature for these products can vary. Some 505(b)(2) drugs carry proprietary brand names, while others are so similar in naming to the reference product that they become referred to by their manufacturer’s name, further contributing to confusion in prescribing, dispensing, and coverage decisions.

Pharmacy Times: What role does medically integrated dispensing (MID) play in supporting efficient biosimilar and generic implementation, and what are some best practices?

Bobolts: By embedding pharmacy services directly within a clinic or provider office, medically integrated dispensing models enhance efficiency, adherence, and can lead to more cost-effective care. Pharmacists in this setting can guide providers to align dispensing with institutional treatment pathways, ensuring preferred biosimilars or generics are used consistently. Some best practices of a MID model include active pharmacist participation in building EHR treatment order sets with the preferred drugs, pharmacist education of clinicians and patients on the preferred drugs and maintaining adequate inventory of preferred drugs to limit the need for variation due to variability in supply.

Pharmacy Times: How can pharmacists effectively collaborate with revenue cycle and prior authorization teams to avoid delays when operationalizing new generic or biosimilar therapies?

Bobolts: Pharmacists play a vital role in minimizing delays and ensuring seamless adoption of new generics, biosimilars, and/or 505(b)(2) drugs. Pharmacists can proactively collaborate with revenue cycle and prior authorization teams to learn the preferred generic, biosimilar, or even 505(b)(2) drugs for the payers commonly serving their patients. This helps ensure the appropriate product is used upfront that meets the coverage determination standards for prior authorization, ultimately expediting authorization, securing reimbursement, and avoiding any unnecessary delays or denials purely based on product selection.

Pharmacy Times: In your experience, how do patient assistance programs and manufacturer copay support differ between originator brands, biosimilars, and 505(b)(2) products?

Bobolts: Patient assistance programs (PAP) and manufacturer copay support can be highly product and manufacturer dependent. Robust PAP and copay programs are more prominent with originator brands then with biosimilars and even far less common, in my experience, with 505(b)(2) products which are usually positioned as cost-saving alternatives to originator brands. One must also be mindful of which products offer PAPs or copay support for those patients in need. If a patient qualifies for a PAP for one product, but the provider and/or payer prefer an alternative product, the patient may need to be enrolled in the new product’s PAP, if one is available.

Pharmacy Times: What policy or regulatory changes would make it easier for health systems and oncology practices to adopt biosimilars and 505(b)(2) agents more broadly?

Bobolts: In my dream world, all biosimilars and 505(b)(2) drugs would be therapeutically interchangeable with the reference drug to allow automatic substitution of the most cost-effective option for the patient. This could increase biosimilar and 505(b)(2) drug adoption, reduce the administrative burden seen with changing products, increase drug competition, and perhaps reduce prices to levels comparable with generic price reductions. A girl can dream, can’t she?