Biotechnology:
FDA rule changes could boost generics
The FDA's new review of
current good manufacturing practice (cGMP) seeks to improve standards of
drug manufacture. At the same time, the regulations should reduce
confusion over biotech-derived drug products. These changes may open the
door to greater use of new manufacturing methods and in the long term,
greater opportunities for biogenerics.
The FDA is overhauling
its current good manufacturing practice (cGMP) certification process for
the first time in 25 years. Since the review includes representatives from
the Center for Biologics Evaluation and Research, the concerns of biotech
industry are likely to be a key consideration.
A key aim of the overhaul
is to "enhance the focus of the agency's cGMP requirements on
potential risks to public health." A second goal is to make it easier
for firms to implement new manufacturing technologies; a final aim is to
make processes more consistent across all the FDA's operations. Together,
the new rules should help companies make better use of technologies and
therapies that have emerged since the cGMP standards were last revised.
In particular, a focus on
risk to public health would give the FDA more flexibility in approving (or
barring) particular technologies. This should allow further development of
technologies such as transgenic chicken or insect production methods,
which currently have no defined approval process. The lack of a clear
route to market has deterred investment in research.
This focus may also
improve the viability of biological generics. At the moment, these pose
little threat to pharma and biotech revenues, due to the limitations of
manufacturing capacity and because they must undergo the same clinical
trials as the original product.
If this review can help
overcome the manufacturing problems, a review of the other barrier to
approval - biological equivalency - could follow. This criterion, which
substantially reduces the number of new trials required for approval, only
makes sense for small molecules. A standard for biogeneric 'equivalency'
would make the launch of biogenerics more attractive.
If the potential to use
modern, high volume manufacturing methods could be combined with the
reduced development costs of a generic, the high value markets of certain
biological therapies would become very attractive.
Related research:
Datamonitor, "Therapeutic Proteins: Strategic Market Analysis and
Forecasts to 2010" (DMHC1803)
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