Are biologics the future?
August 10, 2012
THE next frontier in medicine may
be biologic drugs, according to
Medicines Australia Chief Executive
Dr Brendan Shaw.
The comments follow the launch
of a publication by the International
Federation of Pharmaceutical
Manufacturers & Associations titled
Biotherapeutic Medicines: Grasping
the New Generation of Treatments,
which highlights the dramatic
increase in treatment options
resulting from the development of
biological medicines.
“Biologic medicines and vaccines
represent the cutting edge of
medicine and have the potential to
deliver the most effective means of
treating and diagnosing some of
humanity’s most appalling
diseases,” said Shaw.
“Over 250 innovative human-use
biologics have been approved since
1990 and more than 900 are
currently under development
globally, targeting diseases such as
cancer, AIDS, arthritis, Alzheimer’s
and Parkinson’s,” he added.
Moving forward Shaw said that
biologic medicines could represent
the answer to previously
untreatable illnesses.
MEANWHILE Shaw used the
opportunity to call for Australian
policy makers to institute sound
intellectual property policy and
specific regulatory standards that
would cover the increasing
prevalence of biological
treatments.
“Biologics are more complex and
costly to produce than chemical
medicines,” Shaw said.
“The level of testing and clinical
studies required to compare the
effectiveness of different biologic
medicines presents regulators in
Australia and elsewhere with a new
set of challenges.
“Biologic medicines and their
generic copies, called biosimilars,
are often not interchangeable with
each other in the same way that
chemical-based medicines are, so
regulatory approval systems need
to evolve to cope with evaluating
such medicines,” he added.
Shaw also addressed the issue of
intellectual property protection
regarding biologics, saying it is
“another crucial policy element as
it underpins further research and
development of biologic medicines
and ensures Australians have
access to these medicines as soon
as they become available”.
“This includes assurances that
policies on things like patents and
clinical trial data are up-to-date
with the requirements of biologics
medicines,” he added.
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