Life Sciences Horizons Brochure 2025 - Flipbook - Page 111
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2025 Horizons Life Sciences and Health Care
The evolving biosimilar framework: Moving toward interchangeability and less clinical data
The Biologics Price Competition and Innovation Act
(BPCIA) established a two-tiered abbreviated approval
pathway for biological products, with separate
designations and standards for “biosimilar” and
“interchangeable” biological products. Significantly,
many state laws only allow biosimilar substitution at
the pharmacy level if FDA has made a finding of
interchangeability. In recent years, however, FDA has
signaled a move away from differentiating between
non-interchangeable and interchangeable biosimilars.
In 2023, FDA began taking steps to combat “confusion” that the
safety and efficacy standards differed for non-interchangeable
and interchangeable biosimilars by recommending
interchangeable sponsors no longer specify in labeling that the
product is interchangeable (rather than biosimilar). Most recently,
in June 2024, FDA reversed course by no longer recommending
switching studies to establish interchangeability. In a guidance
update, FDA explained that sponsors may instead provide an
assessment of why comparative analytical and other clinical
data support an interchangeability determination, reducing the
regulatory burden on potential interchangeable applicants. This
change followed on the heels of a meta-analysis published by
FDA officials of studies with a “switch” treatment period, which
reported no difference in safety profiles and immunogenicity
rates between participants who switched between the reference
product and the biosimilar and participants who did not switch.
The result of these developments may be an uptick in
interchangeable biosimilars on the market, an important
potential consequence of which is an increase in substitution
of biosimilars at the pharmacy level. The prior administration
and Congress have supported removal of the statutory distinction
between non-interchangeable and interchangeable biosimilars,
signaling their understandings that new legislation would be
required before the distinction can be eliminated entirely. Absent
new legislation, we expect FDA to continue making individual
interchangeability determinations but anticipate licensure of
more interchangeables generally and earlier in a biosimilar’s
life cycle.
Additionally, for all biosimilars – both non-interchangeable and
interchangeable – FDA appears to be moving away from requiring
comparative efficacy studies to establish biosimilarity. The agency
has made public statements reflecting an increased focus and
reliance on comparative analytical data and belief that clinical
data might be unnecessary given the analytical tools
now available.
As FDA and industry gain more experience with biosimilars,
we expect a continued trend toward streamlining of the data
packages establishing biosimilarity and interchangeability. We
continue to monitor FDA’s action in this area and are keeping a
close eye on proposed legislation in this evolving landscape.
Komal
Karnik Nigam
Partner
Washington, D.C.
Deborah Cho
Counsel
Washington, D.C.
Bryan Walsh
Senior Associate
Washington, D.C.
Katie Kramer
Associate
Washington, D.C.
