The FDA Interchangeability designation enables auto-
substitution at the pharmacy level.1
Find out what INTERCHANGEABILITY can mean for you.
How is auto-substitution possible?
Once the FDA has determined that a biosimilar has met the additional requirements to earn an Interchangeable biosimilar designation, a pharmacist may auto-substitute that product for the reference product.1
- Individual state laws govern how and whether providers must be notified.2
- Auto-substitution is available for both new and existing patients.1
What auto-substitution
with an Interchangeable
biosimilar can do for you.
What auto-substitution with Interchangeable biosimilars means for…
Physicians
High level of certainty.
Physicians can expect the same clinical result with an
Interchangeable biosimilar as they would with the reference
product.1
Increase patients’ speed to therapy vs
non-Interchangeable biosimilars.
Pharmacist-mediated auto-substitution* means fewer
administrative hurdles, so patients can potentially receive
lower-cost medications faster and with fewer hassles.1,3
Communication of substitution.
Individual state laws control how and whether providers
must be notified of the auto-substitution.2
Patients
Continuity of care.
Interchangeable products are studied with multiple switches
vs the reference product to show that there is no greater risk
in terms of safety or diminished efficacy when patients are
switched between the reference product and biosimilar.3
Faster time to treatment vs non-Interchangeable biosimilars.
Pharmacist-mediated auto-substitution* means fewer
administrative hurdles, so patients can potentially receive
their medications faster.1,3
Reduced healthcare costs.
Lower costs can mean greater access for more patients.3
Pharmacists
Streamlined administration.
In many states, pharmacists are permitted to auto-
substitute new and existing patients who are taking a
reference product to its Interchangeable biosimilar.1
Patients benefit.
Pharmacist-mediated auto-substitution* means fewer
administrative hurdles, which can potentially help patients
get their medications faster than they would get non-
Interchangeable biosimilars.1
*Regulations vary by state.
Payors
Enhanced experience.
With the Interchangeability designation, pharmacy-mediated
auto-substitution can help ensure a smooth switch
experience for providers and patients.1
Cost containment.
When more patients have access to lower-cost
medications, the healthcare system saves money.4
Greater patient access.
Cost savings for the system can free up funds to expand
patient access.3
Frequently Asked Questions
Most states in the US have enacted laws regarding auto-substitution of reference products for Interchangeable biosimilars by pharmacists.2 Check with your local pharmacy board or state-level pharmacy laws.
Prescribers and patients can expect that the Interchangeable product will have the same clinical result as the reference product. Prescribers and their patients can be assured that an FDA-approved Interchangeable product has been thoroughly tested and has met the FDA’s high standards for approval. Interchangeable products are studied with multiple switches vs the reference product to show that there is no increased risk or diminished efficacy compared to remaining on the reference product.1
References:
-
1. US Food & Drug Administration website. Prescribing interchangeable
products. https://www.fda.gov/files/drugs/published/Prescribing-Interchangeable-Products.pdf. Accessed December 1, 2020. -
2. Cardinal Health website. State laws for biosimilar interchangeability. https://www.cardinalhealth.com/en/product-solutions/pharmaceutical-products/biosimilars/state-regulations-for-biosimilar.html. Accessed December 14, 2022.
-
3. US Food & Drug Administration website. Biosimilar product regulatory review and approval. https://www.fda.gov/files/drugs/published/Biosimilar-Product-Regulatory-Review-and-Approval.pdf. Accessed November 24, 2020.
-
4. Mulcahy AW, Hlavka JP, Case SR. Biosimilar cost savings in the United
States: initial experience and future potential. RAND Corporation. https://www.rand.org/pubs/perspectives/PE264.html. Accessed December 1, 2020.