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| Process
of pharmaceutical development for generic medication.
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A
new medication drug has two names: one corresponding to
its chemical denomination and the other one to its brand
name. Both are chosen and attributed by the manufacturer.
The brand name is exclusive and can not be used by any
other company. |
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When
a pharmaceutical company finds a new medication and believes
in its future - called at this stage a drug or a chemical
entity - it applies for a patent and obtains an exclusivity
for 20 years duration (according to the countries). This
gives to it the time to manufacture the medication and
to test it in animals and humans before to be able to
put it on the market. The development duration of the
medication determines the price. The longer the medication
needs time to be developed the more expensive it will
be. |
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In
fact, among 10.000 of chemical entities found having a
potential pharmacological activity, just one or two (very
rare) are probably put on the market. |
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When
the patent expires, the manufacturer looses the exclusivity
and other companies can make the product and sale it under
a generic name. Therefore a medication has one brand name
but can has different generic names. |
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The
lawful agencies (ex : Health Canada, FDA, EMEA, etc.)
request that the two products (brand and generic) are
equivalent and demonstrate the same pharmacological behavior.
Since the product is tested on humans, we talk about a
bioequivalence testing.
The
lawful agencies do not make any difference when
inspecting the pharmaceutical companies manufacturing
innovator products or generics, all of them must comply
with the applicable standards. |
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No
medication can be sold without obtaining the approval
of the lawful agencies of the country where the product
will be commercialized.
The Phase I clinical process and the bioequivalence studies
involve usually the healthy volunteers. Dear Volunteers,
if you want to know more about the process of developing
and marketing a medication, please click on the following
link << FAQ/Library>>
and should you have any question, do not hesitate to
contact us. |
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What
about the quality of generic medications? |
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Both
medications (brand and generic) contain the same active
ingredient(s) and have to demonstrate a comparative pharmacological
behavior (absorption, metabolization, distribution and
elimination). |
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The
generic product may have a different color or form in
comparison with the brand one but this does not affect
at all the therapeutic effect of the medication. A patient
can switch from one to the other without experiencing
any difference in the control of the illness. |
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Why
are generic products manufactured and distributed? |
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Given
that the quality is the same, a physician can prescribe
the brand name or the generic, but the pharmacist suggest
to the patient to buy the generic product without needing
the Doctor's approval, except when the patient wants his
physician's opinion. |
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In
the majority of the cases, the RAMQ and certain private
insurance companies refund only the price of the generic
form. Indeed, generic drugs are extremely less expensive,
not because they are less effective but because they undergo
a less long time of manufacturing and thus less expensive
process of pharmaceutical development. |
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