LS&HC Horizons 2022 - Flipbook - Page 43
Hogan Lovells | 2022 2022 Life Sciences and Health Care Horizons
43
Precision and Regenerative Medicine
Complex generics
There is a large and diverse class of innovative
drug products that share one common
denominator: they are extremely difficult to copy.
These products (Complex Generics) include
(1) Complex Active Ingredients, such as low
molecular weight heparin, peptides, nanoparticle
iron, complex mixtures, natural source products:
(2) Complex Formulations, such as liposomes,
microspheres, copolymers, (3) Complex Routes of
Delivery/Locally Acting Drugs, and (4) Complex
Drug-Device Combinations.
As innovation advances in the direction of
increasingly complex, multi-component
systems, we have been monitoring and
analyzing whether FDA has the backing of
science and law to accommodate generic
versions of these complex systems. Complex
Generics have gained attention from high-end
generic sponsors, who see an opportunity to
enter as a lone generic, or a lone 505(b)(2)
competitor, where the norm for most generics
is to enter as one of many in a crowded field.
Funded by user fees from Generic Drug User
Fee Amendments (GDUFA II), FDA 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.
David M. Fox
Partner, Washington, D.C.
Pioneer sponsors who develop products in this
area understand that they can be extremely
difficult to manufacture and characterize,
and that proposed generics may need
extensive data to show “sameness” to the
pioneer: pharmacokinetic studies, in vitro
release studies, physicochemical comparative
studies and, in some cases, comparative
pharmacodynamic or clinical endpoint studies.
FDA, in response, is examining whether
alternative testing models can predict in vivo
release and bioavailability of complex products,
to relieve generics from having to conduct
lengthy in vivo studies. However, the validity of
these models remains unresolved. In addition,
many complex products (e.g., drug-device
combinations) raise difficult comparative
device performance issues.
We remain constantly engaged with the agency
on behalf of our pioneer clients to make sure
the science and the law add up.
Jason Conaty
Counsel, Washington, D.C.
