Interchangeable Biosimilars Have Arrived In The U.S. – Life Sciences, Biotechnology & Nanotechnology

On July 28, 2021, the Food and Drug Administration (FDA) approved the first interchangeable biosimilar
product, Semglee (insulin glargine-yfgn), as a diabetes treatment.
Semglee is both biosimilar to and interchangeable with Lantus
(insulin glargine), a long-acting insulin analog.

When the Biologics Price Competition and Innovation Act (BPCIA)
was enacted in 2010, it granted the FDA the power to approve
biologics that are demonstrated as biosimilar to FDA-approved
reference products. It also made possible an
“interchangeability” designation for biosimilar products
that meet additional requirements. In January 2017, the FDA
published Draft Guidance titled “Considerations in
Demonstrating Interchangeability With a Reference Product.”
The Final Guidance was issued in May 2019.
Semglee’s 2021 approval is the first biosimilar and
interchangeable product approval made by the FDA.

A biosimilar is a biological product that is highly similar to
and has no clinically meaningful differences from an existing
FDA-approved reference product. An interchangeable product, in
addition to being biosimilar, meets additional requirements based
on further evaluation and testing of the product (Section 351(k)(4)
of the Public Health Service Act (PHS Act)). A manufacturer of a
proposed interchangeable product will need to provide additional
information to show that an interchangeable product “can be
expected to produce the same clinical result as the reference
product in any given patient.” See Section
351(k)(4)(A) of the PHS Act. Also, “for a biological product
that is administered more than once to an individual, the risk in
terms of safety or diminished efficacy of alternating or switching
between use of the biological product and the reference product is
not greater than the risk of using the reference product without
such alternation or switch.” See Section 351(k)(4)(B)
of the PHS Act.

Unlike a biosimilar product, an interchangeable product may be
substituted for the reference product without the involvement of
the prescriber. This substitution may occur at the pharmacy, much
like with generic drugs, subject to state pharmacy laws.

The FDA expects to approve more interchangeable biosimilar
products in the future.

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