Home' Australian Pharmacist : Australian Pharmacist February 2012 Contents Australian Pharmacist February 2012 I ©Pharmaceutical Society of Australia Ltd. 107
How generics reach the
Like all new prescription medicines,
generic medicines must first obtain
regulatory approval from the
Therapeutic Goods Administration
(TGA).To do this, generic drug
manufacturers must prove their
product meets the same quality,
safety and efficacy standards
as the originator product. This
is usually done by submitting a
comprehensive data package that
includes detailed information on the
product's formulation, manufacturing
process, specifications and testing
procedures, plus data from clinical
trial bioequivalence studies to
demonstrate that when someone takes
the generic, the drugs' level in the
bloodstream are identical to those of the
For generic medicines to be TGA
approved as interchangeable with the
originator brand, they must meet three
requirements. The active ingredient
must be present in the same quantity
and quality. It must be made in the
same pharmacological formulation
and it must be bioequivalent. (The
plasma concentration of the active
medicine cannot vary by more than
10% between the generic and initial
brand formulation. In most cases it is
The TGA evaluates the data and
where the appropriate standards
and requirements have been met,
registers the product and verifies
that the generic is bioequivalent to
the originator product. The generics
manufacturer then submits a request to
the Pharmaceutical Benefits Branch for
The process, from performing
bioequivalence studies, submitting to
the TGA and obtaining PBS listing takes
approximately two years. This does
not take into account research and
development completed to develop the
product to be identical to the originator,
which can be more than five years.
*Information provided by Ranbaxy
and engendering public confidence to
choose a generic brand.'
'The Government is missing out on
making significant savings because
the follow-on generic medicine is
not dispensed as often as it could be,'
Ms Lynch said.
Beyond raising consumer awareness,
other generic medicines players believe
the Government should be doing more
to support generic substitution.
'In the US, 78% of dispensed medicines
are generics, compared to about 38% in
Australia. Government needs to look at
new policies that further encourage their
use, such as actively endorsing products.
The FDA openly backs generics and puts
its name to their quality. The TGA here
doesn't do that, yet every time generic
medicines are dispensed taxpayers are
saving money,' Dr Martin Cross said.
Medicines Australia is also calling for a
more supportive policy environment
to encourage innovation, research and
manufacturing in Australia.
'It is a perfect industry for a country
trying to develop a smart, high-wage,
high-skill, innovative, low carbon
economy, but we do need the right
policy settings. We need to be part of
the manufacturing debate and need to
look carefully at the recommendations
of the Pharmaceuticals Industry Strategy
Group report including an industry
More reform to come?
Just as 2012 promises to be a year of
change for the medicines industry,
and the ink has barely dried on the
latest MOU between Government and
Industry, many believe further reforms
aren't far away.
'It is a perfect industry for a country trying to develop
a smart, high-wage, high-skill, innovative,
low carbon economy.'
'I don't think we've seen the end of
Government seeking price cuts and I
don't believe drug deferral is off the
agenda. Government is trying to reduce
growth of high cost drugs and it will be
looking for more cuts from suppliers,'
Bruce Annabel said.
Mr Evans concurs, saying it's reasonable
to expect we have not seen the last of
Government reform initiatives.
Their predictions are in line with
warnings from shadow Health Minister,
Peter Dutton, who pointed out the
vulnerability of the PBS.
'The Government's own
Intergenerational Report says that
spending on the PBS is on a sustainable
basis. Any further pressure for PBS
reform won't be to sustain delivery
of medicines. It will be driven by this
Government's needs to make savings
because of its out-of-control spending
and huge debt,' he said.
The then Health Minister, Nicola Roxon,
declined to comment.
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