Key Takeaways
- Biosimilars can lower drug costs and improve access, but provider hesitancy persists due to efficacy and safety concerns.
- FDA interchangeability designation allows pharmacists to substitute biosimilars, but state regulations vary, requiring careful navigation.
- Pharmacists must manage insurance coverage complexities and educate patients on biosimilar options and financial assistance programs.
- As more biosimilars gain FDA approval, pharmacists' roles in selection, compliance, and patient education will expand.
This article was originally published by Pharmacy Times®. This version has been lightly edited.
The proliferation of biosimilars, which has accelerated in recent years, has the chance to lower the cost of prescription drugs across countless conditions for millions of individuals. Medications for chronic diseases are often coupled with significant price tags and cause long-term financial stress, which makes managing the conditions even more burdensome. Not only can biosimilars reduce prices for myriad drugs, but they can also improve patient access to medications and make prescribing easier for the pharmacist.1
Still, many providers harbor a reluctance to prescribe biosimilars because of their lack of comfort with their efficacy or safety compared with a reference biologic. There are also complex hurdles and restrictions created by the FDA regulating the use of biosimilars, which can make it difficult for patients and providers to understand which treatments are available for them and at what price.1,2
The ability to designate biosimilars as “interchangeable” (those that demonstrate enhanced clinical similarity with a reference product) has allowed pharmacists greater flexibility. Still, interchangeability rules vary by state and only apply to a handful of treatments. Pharmacists must educate not only themselves but other members of the patient care team as well as patients on regulations, feasibility, and processes surrounding biosimilar substitution.1,2
The Interchangeability Process
Interchangeable biosimilars must satisfy multiple conditions to be automatically substituted for an original reference biologic. The conditions include the following2,3:
- It must be a biosimilar approved by the FDA.
- It must produce the same clinical outcomes as the reference product in any patient for any approved indication.
- If a biosimilar is given more than once to the same patient—whether switching or alternating with the reference product—it must sustain similar efficacy and have no greater risk of adverse events.
Although the FDA is responsible for deeming biosimilars interchangeable, it is the responsibility of pharmacists to properly select biosimilars they know are available and as effective as the reference biologic.2,3
States have varying regulations surrounding the automatic substitution from a reference biologic to an interchangeable biosimilar. However, the FDA allows pharmacists to substitute a reference product without the approval of a prescribing physician. Despite the lack of uniformity, 46 of the 50 states allow for that FDA standard (the exceptions are Alabama, Indiana, South Carolina, and Washington).2 Pharmacists should ensure they are complying with specific state laws regarding biosimilar interchangeability and maintain sustained communication and accurate recordkeeping at an individual patient level.2,3
Pharmacists cannot freely substitute a reference biologic for a biosimilar product without an FDA interchangeability designation. These cases require that a prescription for the biosimilar is written specifically by a prescriber, indicating it is safe to switch from the reference product. Proper awareness of which medications are considered interchangeable is an essential component of pharmacist biosimilar management.2,3
Cost-Effectiveness Considerations
Navigating insurance coverage is another critical aspect of biosimilar prescribing. Insurance companies typically provide coverage for biosimilars, but pharmacists should ensure they understand all relevant individual considerations for a patient’s coverage of biosimilars. Some factors to consider when deciding on a biosimilar for a patient are the type of insurance plan the patient is enrolled in and their formulary coverage, which can significantly affect biosimilar eligibility.4
Pharmacists can consult directly with plan providers for patients on Medicare and Medicaid to discuss their eligibility for biosimilar coverage. Beyond communicating directly with insurance providers, pharmacists can educate and empower patients regarding manufacturer co-pay cards and programs to help patients pay for their insurance, which could help reduce the financial burden that may be associated with the cost of biosimilars.4
Selecting the Correct Biosimilar
Choosing which biosimilar to use for a patient’s condition can be challenging. Pharmacists in all spaces, whether community or health system pharmacists, should educate themselves about the biosimilars that have been approved by the FDA thus far as well as those that are further down the pipeline but expected to become available. Pharmacists can review resources to stay current on approved biosimilars of proven indications and can provide important input into decisions regarding the proper use of biosimilars in health facilities.1,3
With a unique position as members of the patient’s multidisciplinary team, pharmacists can appropriately evaluate biosimilars based on each patient’s concerns and requests. Pharmacists in the clinical setting can provide a holistic view of the biosimilar products’ clinical profile and other important considerations, including proper storage, shelf life, and other aspects relating
to the supply chain.
Pharmacists play an important role in the substitution of biosimilars and patient education surrounding their use. The role of pharmacists in this space will only continue to grow as more biosimilars gain FDA-approved interchangeability status.
REFERENCES
1. Okoro RN. Biosimilar medicines uptake: the role of the clinical pharmacist. Explor Res Clin Soc Pharm. 2021;1:100008.doi:10.1016/j.rcsop.2021.100008
2. Humphreys S. Understanding interchangeable biosimilars at the federal and state levels. Am J Manag Care. 2023;29:SP545-SP548. doi:10.37765/ajmc.2023.89419
3. Overview of biologics and biosimilar products. American Pharmacists Association. Accessed February 19, 2025. https://www.pharmacist.com/Advocacy/Issues/Biosimilars
