The purpose of the Biologics Price Competition and Innovation Act that gave FDA authority
to approve biosimilar and interchangeable products is intended to increase access to
these very important and lifesaving critical medications to the American public.
The act defines an interchangeable product as one that may be substituted for the reference
product without the intervention of the health care provider who prescribed the product.
For an interchangeable product, beyond demonstrating that the products are biosimilar so that data
that supports that it’s highly similar with no clinically meaningful differences, there
are these additional statutory standards that need to be met.
The first one is the expectation that the product will produce the same clinical result
in any given patient.
So again, it’ll work the same way in any patient that’s taken the medication.
And FDA has approached that by saying that the application needs to include data or information
to support that, that even if they are not seeking approval or licensure for every condition
of use, every indication that the reference product is approved for, that what’s in
their application is sufficient to demonstrate that expectation.
So they have to give you data and information to address all the conditions of use for all
the populations to show it wouldn’t work any differently in any of the reference product’s
labeled conditions of use.
In addition to that, for a product that is administered to a patient or given to a patient
more than once, that the impact of switching back and forth between the interchangeable
product and the reference product is evaluated in comparison to just staying on the reference
product.
So that is what we call a switching study.
And that would be a pre-approval study that’s conducted where you have a group of patients
that’s just given the reference product on whatever dosing or normal clinical schedule
it be given.
And they’re compared to patients who would go back and forth between products.
And then at the end of the day, you look and make sure that they have the same safety,
the same effectiveness, they work the same way, you have the same exposure in the body
over time, through that switching period.
So you’re not going to have any differences in between.
And so those are the standards that we have to meet, that the applicant needs to meet,
and the types of data that we would expect to support those standards.
There isn’t an expectation of substitution for biosimilar products.
There is an expectation of substitution for interchangeable products.
And that’s why we look for that additional data and information, that additional evaluation
to support how that product is going to be used in the marketplace.
For a biosimilar product, if the prescriber writes a prescription for that biosimilar
product and the patient took it to the pharmacy and said, “Here’s my prescription,”
their prescription would be filled with whatever is written on their specific prescription
from their provider.
If it’s an interchangeable product, and it’s written for the reference product,
they can take that to the pharmacy and they may be substituted the interchangeable product.
And that is that pharmacy-level substitution.
But it’s important to remember that pharmacy-level substitution is actually overseen at the state
level, not at the federal level.
So it’s the state laws and, ultimately, the state boards of pharmacy that make decisions
about the substitution of products, and that would include the substitution of biological
products as well.
If a patient has questions about the biological product they receive, they should talk to
their doctor, pharmacist and/or insurance company to find out more information.
So when FDA approves a biosimilar or an interchangeable product, health care providers and patients
can rely on FDA’s approval of that product.
FDA will not approve a biosimilar or interchangeable product if it is not safe and effective for
its labeled conditions of use.
So we want to ensure the health care community and patients that they can rely that FDA is
applying rigorous approval standards and manufacturing standards to both biosimilar and interchangeable
products in the same way that they would apply very rigorous standards to the reference or
originator products.