LSHC Horizons Brochure 2024 - Flipbook - Page 90
Hogan Lovells | 2024 Life Sciences and Health Care Horizons | United States
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Complex generics
As a part of its stated goal to encourage market
competition, FDA continues to provide support
for the development of complex generics, i.e.,
products that are difficult to copy given their
use of complex active ingredients (peptides,
nucleic acids, nanoparticles, macromolecular
entities), complex formulations (liposomes,
micelles, microspheres, copolymers), complex
routes of delivery and dosage forms, innovative
devices, or digital systems.
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, spons
ors increasingly look to the more flexible
505(b)(2) pathway and attempt to obtain
an “A” therapeutic equivalence rating.
FDA continues to provide substantive
guidance and recommendations for complex
generic manufacturers on overcoming
development and manufacturing challenges
and demonstrating therapeutic equivalence.
In 2024, FDA plans to publish over 30 new
product-specific guidances for complex
products. And in March, FDA will co-host
a workshop with the Center for Research
on Complex Generics (CRCG) to unpack
demonstrating generic substitutability for
drug-device combination products. We will
monitor these developments to identify trends
and the evolving standards for generic versions
of innovator products.
Jason F. Conaty
Counsel
Washington, D.C.
Eva Marie Schifini
Associate
Los Angeles
Band One for Life
Sciences: Regulatory/
Compliance,
Chambers USANationwide, 2024
