LS&HC Horizons 2023 - Flipbook - Page 72
Hogan Lovells | 2023 Life Sciences and Health Care Horizons | United States
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Complex generics
Many new drugs include complex active
ingredients (peptides, nucleic acids,
natural-source mixtures, nanoparticles,
macromolecular entities), complex
formulations (liposomes, micelles,
microspheres, copolymers), innovative devices,
and digital systems. These complex products
share one common denominator: they are
difficult to copy.
A major part of our practice is lifecycle
management counseling for pioneer sponsors
in this space. FDA views these complex
innovative systems as a challenge to generic
entry – one to be solved. The agency has
coined the term “Complex Generics”. Funded
by user fees from Generic Drug User Fee
Amendments (GDUFA III), the agency has
invested substantial research dollars into the
development of new scientific tools and new
forms of scientific and regulatory thinking to
adapt – if possible – the generic drug approval
system to fit these complex products.
Pioneer sponsors in this area understand
it is extremely difficult to manufacture and
characterize these products. Aspiring generics
need extensive data to show “sameness”, and
for products that include delivery systems,
the useability of the generic versus the pioneer
product is a key consideration.
We carefully study the approaches FDA
proposes for generics, to identify standards that
either do not reflect the full complexity of the
innovator product, or are in tension with steps
taken by pioneers to ensure the consistency and
precision of the product. Our pioneer clients
rely on our legal and scientific fluency to ensure
FDA honors the science, and the law, to guard
against the agency taking a leap of faith at the
expense of public health.
Complex Generics have gained attention
from high-end generic sponsors, who see an
opportunity to enter as a lone generic where
the norm for most generics is to enter as
one of many in a crowded field. Or when the
generic system fails to accommodate, sponsors
increasingly look to the more flexible 505(b)(2)
pathway and still attempt to grasp an “A”
therapeutic equivalence rating.
David M. Fox
Partner, Washington, D.C.
Jason F. Conaty
Counsel, Washington, D.C.
Bryan Walsh
Associate, Washington, D.C.